Depression, Anxiety, Engagement, Patient
Conditions
Keywords
Breast Cancer
Brief summary
The overarching goals of this project are to provide the first rigorous test of a scalable and publicly accessible mobile health intervention (IntelliCare) to address emotional distress in women with breast cancer, and to test the impact of human coaching as a way to increase engagement with digital health interventions to improve outcomes. To achieve these goals, an innovative experimental study design, known as a Sequential, Multiple Assignment, Randomized Trial (SMART), will be used to test the effects of the IntelliCare apps on symptoms of depression and anxiety, as well as the added value of human support to improve participant engagement. 313 breast cancer survivors diagnosed within the past 5 years and who screen positive for elevated symptoms of depression and/or anxiety will be recruited. Participants will initially be randomized to receive the IntelliCare apps or app-delivered patient education (control) for 8 weeks, and the impact of the IntelliCare apps on reducing symptoms of depression and anxiety in breast cancer survivors relative to control will be tested (Aim 1). We will monitor the app usage data of participants who receive the IntelliCare apps. Those who are high-engagers will continue to use the apps with no change. Those who are low-to-moderate engagers will be rerandomized after 1 week to either receive added coaching vs. not (i.e., no change) in addition to the apps. The hypothesis is that added coaching to address barriers to app usage will lead to greater engagement with the apps (Aim 2), for low-to-moderate engagers. Finally, semi-structured exit interviews will be conducted with participants that receive the IntelliCare apps and coaching. Interviews will capture survivors' perceptions about the extent to which, and how, tailoring the apps and coaching specifically for breast cancer survivors may improve intervention outcomes and engagement (Aim 3).
Interventions
BEHAVIORALIntelliCare
IntelliCare is a self-guided, fully automated suite of 6 apps designed for brief, frequent check-ins to promote skill acquisition. IntelliCare has been shown in both general deployment and human-supported trials to be efficacious in reducing symptoms of depression and anxiety.
BEHAVIORALPsychoeducation
The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
BEHAVIORALCoaching
The randomization of added coaching vs. no added coaching after 1 week will only be carried out in the IntelliCare group. Coaching is a human supported approach to optimizing the use and benefit of the IntelliCare apps.
Sponsors
Northwestern University
National Cancer Institute (NCI)
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Sequential, Multiple Assignment, Randomized Trial (SMART)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥ 18 years (age 19 if in Nebraska, given age of consent); 2. 0-5 years post-diagnosis of Stage I, II, or III female breast cancer; 3. elevated symptoms of depression as measured by the Patient Health Questionnaire-8 (PHQ-8) score ≥ 10 and/or symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) score ≥ 8.
Exclusion criteria
1. Taking antidepressant medication and have had an appointment to adjust the dosage over the past 2 weeks; 2. mental health condition deemed to interfere with study procedures or put the participant at undue risk based on self-reported history of psychosis or bipolar disorder, or active suicidal ideation that necessitates more intense care; 3. do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later); 4. cannot read and speak English (current intervention only available in English).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-8 | Baseline | 8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression. |
| Generalized Anxiety Disorder-7 | Baseline | 7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| App Engagement From App Session Duration | Duration in seconds of app sessions from Baseline through 8 weeks | Duration in seconds of app sessions from Baseline through 8 weeks |
| App Engagement From App Downloads | Number of apps downloaded from Baseline through 8 weeks | Number of apps downloaded from Baseline through 8 weeks |
| 36-Item Short Form Survey - Physical Health | Baseline | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. |
| 36-Item Short Form Survey - Mental Health | Baseline | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. |
| Multidimensional Fatigue Symptom Inventory-Short Form | Baseline | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. |
| Pittsburgh Sleep Quality Index | Baseline | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. |
| Alcohol Use Disorders Identification Test | Baseline | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). |
| PROMIS Global Mental Health v1.2 | Baseline | The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome. |
| UAMS Health Literacy Measure | Baseline | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. |
| Penn State Worry Questionnaire | Baseline | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. |
| Ten Item Personality Inventory- Extraversion | Baseline | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion. |
| Ten Item Personality Inventory - Extraversion | 8 weeks | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion. |
| Ten Item Personality Inventory - Agreeableness | Baseline | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness. |
| Ten Item Personality Inventory - Conscientiousness | Baseline | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness. |
| Ten Item Personality Inventory - Neuroticism | Baseline | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism. |
| Ten Item Personality Inventory - Openness | Baseline | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness. |
| TWente Engagement With Ehealth Technologies Scale (TWEETS) | Baseline | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. |
| PROMIS Satisfaction With Sex Life | Baseline | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. |
| App Engagement From App Sessions | Frequency of unique app sessions from Baseline through 8 weeks | Frequency of unique app sessions from Baseline through 8 weeks based on median number of app sessions |
Other
| Measure | Time frame | Description |
|---|---|---|
| Digital Intervention Evaluation Questionnaire | 8 weeks | A 12-item questionnaire with subscales of perceived utility and perceived impact of digital interventions. Each item is rated on a 0 (not at all) to 5 (very) scale and the items are summed to compute a total score ranging from 0-60. Higher scores indicate higher perceived utility and impact of a digital intervention. |
| Digital Intervention Adherence Questionnaire | 8 weeks | A 26 item questionnaire that assesses perceived adherence to a digital intervention due to barriers to use. Each item is scored on a 0 (not at all) to 2 (very) scale and the items are summed to compute a total score ranging from 0-52. Higher scores indicate lower perceived adherence to a digital intervention due to barriers to use. |
Countries
United States
Participant flow
Pre-assignment details
3 participants withdrew from the study shortly after being randomized to IntelliCare and never accessed the program. They are therefore not included in any IntelliCare subgroups (i.e., IntelliCare - High Engager, No Coaching; IntelliCare - Low Engager, No Coaching; IntelliCare - Low Engager, Coaching). Subgroup assignment is based on participant engagement with IntelliCare, and because these participants withdrew before engaging with the program, they do not fit into any IntelliCare subgroup.
Participants by arm
| Arm | Count |
|---|---|
| IntelliCare - High Engager, No Coaching This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual. | 134 |
| IntelliCare - Low Engager, No Coaching This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual. | 38 |
| IntelliCare - Low Engager, Coaching This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach. | 34 |
| Patient Education The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms. | 104 |
| Total | 310 |
Baseline characteristics
| Characteristic | IntelliCare - High Engager, No Coaching | IntelliCare - Low Engager, No Coaching | IntelliCare - Low Engager, Coaching | Patient Education | Total |
|---|---|---|---|---|---|
| Age, Continuous | 51.4 years STANDARD_DEVIATION 10.7 | 50.0 years STANDARD_DEVIATION 10.9 | 50.2 years STANDARD_DEVIATION 10.9 | 52.2 years STANDARD_DEVIATION 10.2 | 51.6 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 2 Participants | 2 Participants | 5 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 124 Participants | 36 Participants | 32 Participants | 96 Participants | 288 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 5 Participants | 4 Participants | 7 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 1 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 120 Participants | 32 Participants | 28 Participants | 91 Participants | 271 Participants |
| Sex: Female, Male Female | 134 Participants | 38 Participants | 34 Participants | 104 Participants | 310 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 137 | 0 / 38 | 0 / 34 | 2 / 104 |
| other Total, other adverse events | 0 / 137 | 0 / 38 | 0 / 34 | 0 / 104 |
| serious Total, serious adverse events | 0 / 137 | 0 / 38 | 0 / 34 | 0 / 104 |
Outcome results
Primary
Generalized Anxiety Disorder-7
7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
Time frame: Post 8 weeks
Population: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Generalized Anxiety Disorder-7 | 6.9 score on a scale | Standard Deviation 4.6 |
| IntelliCare - Low Engager, No Coaching | Generalized Anxiety Disorder-7 | 7.6 score on a scale | Standard Deviation 4.5 |
| IntelliCare - Low Engager, Coaching | Generalized Anxiety Disorder-7 | 7.7 score on a scale | Standard Deviation 5.1 |
| Patient Education | Generalized Anxiety Disorder-7 | 8.9 score on a scale | Standard Deviation 5.5 |
Primary
Generalized Anxiety Disorder-7
7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
Time frame: 6 month follow up
Population: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Generalized Anxiety Disorder-7 | 6.3 score on a scale | Standard Deviation 5 |
| IntelliCare - Low Engager, No Coaching | Generalized Anxiety Disorder-7 | 7.0 score on a scale | Standard Deviation 4.6 |
| IntelliCare - Low Engager, Coaching | Generalized Anxiety Disorder-7 | 7.3 score on a scale | Standard Deviation 5.7 |
| Patient Education | Generalized Anxiety Disorder-7 | 8.0 score on a scale | Standard Deviation 5.5 |
Primary
Generalized Anxiety Disorder-7
7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
Time frame: 12 month follow up
Population: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Generalized Anxiety Disorder-7 | 5.7 score on a scale | Standard Deviation 5.1 |
| IntelliCare - Low Engager, No Coaching | Generalized Anxiety Disorder-7 | 6.0 score on a scale | Standard Deviation 4.2 |
| IntelliCare - Low Engager, Coaching | Generalized Anxiety Disorder-7 | 7.2 score on a scale | Standard Deviation 5.6 |
| Patient Education | Generalized Anxiety Disorder-7 | 7.5 score on a scale | Standard Deviation 5.8 |
Primary
Generalized Anxiety Disorder-7
7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
Time frame: Baseline
Population: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Generalized Anxiety Disorder-7 | 11.4 score on a scale | Standard Deviation 4 |
| IntelliCare - Low Engager, No Coaching | Generalized Anxiety Disorder-7 | 12.2 score on a scale | Standard Deviation 5 |
| IntelliCare - Low Engager, Coaching | Generalized Anxiety Disorder-7 | 12.4 score on a scale | Standard Deviation 5.2 |
| Patient Education | Generalized Anxiety Disorder-7 | 12.6 score on a scale | Standard Deviation 4.7 |
Primary
Patient Health Questionnaire-8
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
Time frame: Baseline
Population: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Patient Health Questionnaire-8 | 12.1 score on a scale | Standard Deviation 4.6 |
| IntelliCare - Low Engager, No Coaching | Patient Health Questionnaire-8 | 11.8 score on a scale | Standard Deviation 4.1 |
| IntelliCare - Low Engager, Coaching | Patient Health Questionnaire-8 | 12.5 score on a scale | Standard Deviation 4.5 |
| Patient Education | Patient Health Questionnaire-8 | 12.7 score on a scale | Standard Deviation 4.4 |
Primary
Patient Health Questionnaire-8
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
Time frame: Post 8 weeks
Population: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Patient Health Questionnaire-8 | 8.1 score on a scale | Standard Deviation 5.1 |
| IntelliCare - Low Engager, No Coaching | Patient Health Questionnaire-8 | 10.5 score on a scale | Standard Deviation 5.8 |
| IntelliCare - Low Engager, Coaching | Patient Health Questionnaire-8 | 7.2 score on a scale | Standard Deviation 4.4 |
| Patient Education | Patient Health Questionnaire-8 | 9.4 score on a scale | Standard Deviation 4.9 |
Primary
Patient Health Questionnaire-8
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
Time frame: 6 month follow up
Population: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Patient Health Questionnaire-8 | 7.2 score on a scale | Standard Deviation 4.9 |
| IntelliCare - Low Engager, No Coaching | Patient Health Questionnaire-8 | 7.4 score on a scale | Standard Deviation 4.3 |
| IntelliCare - Low Engager, Coaching | Patient Health Questionnaire-8 | 7.2 score on a scale | Standard Deviation 5.1 |
| Patient Education | Patient Health Questionnaire-8 | 8.8 score on a scale | Standard Deviation 5.5 |
Primary
Patient Health Questionnaire-8
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
Time frame: 12 month follow up
Population: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Patient Health Questionnaire-8 | 6.7 score on a scale | Standard Deviation 4.9 |
| IntelliCare - Low Engager, No Coaching | Patient Health Questionnaire-8 | 7.4 score on a scale | Standard Deviation 3.9 |
| IntelliCare - Low Engager, Coaching | Patient Health Questionnaire-8 | 6.6 score on a scale | Standard Deviation 5.6 |
| Patient Education | Patient Health Questionnaire-8 | 8.3 score on a scale | Standard Deviation 5.9 |
Secondary
36-Item Short Form Survey - Mental Health
The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | 36-Item Short Form Survey - Mental Health | 68.7 score on a scale | Standard Deviation 16.9 |
| IntelliCare - Low Engager, No Coaching | 36-Item Short Form Survey - Mental Health | 66.2 score on a scale | Standard Deviation 14.6 |
| IntelliCare - Low Engager, Coaching | 36-Item Short Form Survey - Mental Health | 64.5 score on a scale | Standard Deviation 18.7 |
| Patient Education | 36-Item Short Form Survey - Mental Health | 63.1 score on a scale | Standard Deviation 19.6 |
Secondary
36-Item Short Form Survey - Mental Health
The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | 36-Item Short Form Survey - Mental Health | 54.2 score on a scale | Standard Deviation 16.3 |
| IntelliCare - Low Engager, No Coaching | 36-Item Short Form Survey - Mental Health | 47.9 score on a scale | Standard Deviation 16.8 |
| IntelliCare - Low Engager, Coaching | 36-Item Short Form Survey - Mental Health | 48.2 score on a scale | Standard Deviation 14.6 |
| Patient Education | 36-Item Short Form Survey - Mental Health | 48.6 score on a scale | Standard Deviation 16.9 |
Secondary
36-Item Short Form Survey - Mental Health
The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | 36-Item Short Form Survey - Mental Health | 69.6 score on a scale | Standard Deviation 16.4 |
| IntelliCare - Low Engager, No Coaching | 36-Item Short Form Survey - Mental Health | 60.7 score on a scale | Standard Deviation 19 |
| IntelliCare - Low Engager, Coaching | 36-Item Short Form Survey - Mental Health | 60.3 score on a scale | Standard Deviation 20.9 |
| Patient Education | 36-Item Short Form Survey - Mental Health | 61.3 score on a scale | Standard Deviation 17.4 |
Secondary
36-Item Short Form Survey - Mental Health
The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | 36-Item Short Form Survey - Mental Health | 62.7 score on a scale | Standard Deviation 17.5 |
| IntelliCare - Low Engager, No Coaching | 36-Item Short Form Survey - Mental Health | 59.3 score on a scale | Standard Deviation 18.2 |
| IntelliCare - Low Engager, Coaching | 36-Item Short Form Survey - Mental Health | 57.8 score on a scale | Standard Deviation 19.5 |
| Patient Education | 36-Item Short Form Survey - Mental Health | 55.3 score on a scale | Standard Deviation 18.3 |
Secondary
36-Item Short Form Survey - Physical Health
The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Time frame: 8 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | 36-Item Short Form Survey - Physical Health | 44.7 score on a scale | Standard Deviation 41.9 |
| IntelliCare - Low Engager, No Coaching | 36-Item Short Form Survey - Physical Health | 45.8 score on a scale | Standard Deviation 36.6 |
| IntelliCare - Low Engager, Coaching | 36-Item Short Form Survey - Physical Health | 53.8 score on a scale | Standard Deviation 41.5 |
| Patient Education | 36-Item Short Form Survey - Physical Health | 44.5 score on a scale | Standard Deviation 40.2 |
Secondary
36-Item Short Form Survey - Physical Health
The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | 36-Item Short Form Survey - Physical Health | 65.9 score on a scale | Standard Deviation 41.3 |
| IntelliCare - Low Engager, No Coaching | 36-Item Short Form Survey - Physical Health | 52.3 score on a scale | Standard Deviation 41.6 |
| IntelliCare - Low Engager, Coaching | 36-Item Short Form Survey - Physical Health | 56.0 score on a scale | Standard Deviation 42.5 |
| Patient Education | 36-Item Short Form Survey - Physical Health | 56.8 score on a scale | Standard Deviation 41.8 |
Secondary
36-Item Short Form Survey - Physical Health
The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | 36-Item Short Form Survey - Physical Health | 35.5 score on a scale | Standard Deviation 40.9 |
| IntelliCare - Low Engager, No Coaching | 36-Item Short Form Survey - Physical Health | 41.4 score on a scale | Standard Deviation 36.9 |
| IntelliCare - Low Engager, Coaching | 36-Item Short Form Survey - Physical Health | 39.7 score on a scale | Standard Deviation 42.2 |
| Patient Education | 36-Item Short Form Survey - Physical Health | 35.7 score on a scale | Standard Deviation 39.4 |
Secondary
36-Item Short Form Survey - Physical Health
The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | 36-Item Short Form Survey - Physical Health | 60.3 score on a scale | Standard Deviation 42.1 |
| IntelliCare - Low Engager, No Coaching | 36-Item Short Form Survey - Physical Health | 51.5 score on a scale | Standard Deviation 41 |
| IntelliCare - Low Engager, Coaching | 36-Item Short Form Survey - Physical Health | 56.5 score on a scale | Standard Deviation 45.2 |
| Patient Education | 36-Item Short Form Survey - Physical Health | 49.0 score on a scale | Standard Deviation 40.1 |
Secondary
Alcohol Use Disorders Identification Test
The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Alcohol Use Disorders Identification Test | 2.0 score on a scale | Standard Deviation 3.4 |
| IntelliCare - Low Engager, No Coaching | Alcohol Use Disorders Identification Test | 3.5 score on a scale | Standard Deviation 5.1 |
| IntelliCare - Low Engager, Coaching | Alcohol Use Disorders Identification Test | 1.9 score on a scale | Standard Deviation 2.6 |
| Patient Education | Alcohol Use Disorders Identification Test | 1.5 score on a scale | Standard Deviation 2.7 |
Secondary
Alcohol Use Disorders Identification Test
The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Alcohol Use Disorders Identification Test | 2.0 score on a scale | Standard Deviation 3.2 |
| IntelliCare - Low Engager, No Coaching | Alcohol Use Disorders Identification Test | 3.7 score on a scale | Standard Deviation 5.9 |
| IntelliCare - Low Engager, Coaching | Alcohol Use Disorders Identification Test | 1.7 score on a scale | Standard Deviation 3 |
| Patient Education | Alcohol Use Disorders Identification Test | 1.7 score on a scale | Standard Deviation 3.1 |
Secondary
Alcohol Use Disorders Identification Test
The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Alcohol Use Disorders Identification Test | 2.3 score on a scale | Standard Deviation 3.4 |
| IntelliCare - Low Engager, No Coaching | Alcohol Use Disorders Identification Test | 4.0 score on a scale | Standard Deviation 5.4 |
| IntelliCare - Low Engager, Coaching | Alcohol Use Disorders Identification Test | 2.2 score on a scale | Standard Deviation 2.9 |
| Patient Education | Alcohol Use Disorders Identification Test | 1.7 score on a scale | Standard Deviation 2.8 |
Secondary
Alcohol Use Disorders Identification Test
The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Alcohol Use Disorders Identification Test | 1.7 score on a scale | Standard Deviation 2.9 |
| IntelliCare - Low Engager, No Coaching | Alcohol Use Disorders Identification Test | 3.3 score on a scale | Standard Deviation 5.3 |
| IntelliCare - Low Engager, Coaching | Alcohol Use Disorders Identification Test | 1.6 score on a scale | Standard Deviation 2.6 |
| Patient Education | Alcohol Use Disorders Identification Test | 1.5 score on a scale | Standard Deviation 2.6 |
Secondary
App Engagement From App Downloads
Number of apps downloaded from Baseline through 8 weeks
Time frame: Number of apps downloaded from Baseline through 8 weeks
Population: Technical problems led to not being able to extract app engagement based on number of app downloads from any participants. Data related to the gold standard metric of number of app sessions was captured and reported.
Secondary
App Engagement From App Session Duration
Duration in seconds of app sessions from Baseline through 8 weeks
Time frame: Duration in seconds of app sessions from Baseline through 8 weeks
Population: Technical problems led to not being able to extract app engagement based on app session duration from any participants. Data related to the gold standard metric of number of app sessions was captured and reported.
Secondary
App Engagement From App Sessions
Frequency of unique app sessions from Baseline through 8 weeks based on median number of app sessions
Time frame: Frequency of unique app sessions from Baseline through 8 weeks
Population: Includes only participants who downloaded their assigned app or intervention.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | App Engagement From App Sessions | Week 1 | 12 app sessions |
| IntelliCare - High Engager, No Coaching | App Engagement From App Sessions | Week 2 | 9 app sessions |
| IntelliCare - High Engager, No Coaching | App Engagement From App Sessions | Week 3 | 8 app sessions |
| IntelliCare - High Engager, No Coaching | App Engagement From App Sessions | Week 4 | 7 app sessions |
| IntelliCare - High Engager, No Coaching | App Engagement From App Sessions | Week 5 | 6 app sessions |
| IntelliCare - High Engager, No Coaching | App Engagement From App Sessions | Week 6 | 5 app sessions |
| IntelliCare - High Engager, No Coaching | App Engagement From App Sessions | Week 7 | 5 app sessions |
| IntelliCare - High Engager, No Coaching | App Engagement From App Sessions | Week 8 | 4 app sessions |
| IntelliCare - Low Engager, No Coaching | App Engagement From App Sessions | Week 6 | 1 app sessions |
| IntelliCare - Low Engager, No Coaching | App Engagement From App Sessions | Week 5 | 2 app sessions |
| IntelliCare - Low Engager, No Coaching | App Engagement From App Sessions | Week 2 | 4 app sessions |
| IntelliCare - Low Engager, No Coaching | App Engagement From App Sessions | Week 8 | 0.5 app sessions |
| IntelliCare - Low Engager, No Coaching | App Engagement From App Sessions | Week 7 | 0.5 app sessions |
| IntelliCare - Low Engager, No Coaching | App Engagement From App Sessions | Week 4 | 1 app sessions |
| IntelliCare - Low Engager, No Coaching | App Engagement From App Sessions | Week 3 | 2.5 app sessions |
| IntelliCare - Low Engager, No Coaching | App Engagement From App Sessions | Week 1 | 6 app sessions |
| IntelliCare - Low Engager, Coaching | App Engagement From App Sessions | Week 7 | 4.5 app sessions |
| IntelliCare - Low Engager, Coaching | App Engagement From App Sessions | Week 3 | 5 app sessions |
| IntelliCare - Low Engager, Coaching | App Engagement From App Sessions | Week 4 | 5 app sessions |
| IntelliCare - Low Engager, Coaching | App Engagement From App Sessions | Week 5 | 3.5 app sessions |
| IntelliCare - Low Engager, Coaching | App Engagement From App Sessions | Week 6 | 4 app sessions |
| IntelliCare - Low Engager, Coaching | App Engagement From App Sessions | Week 8 | 3.5 app sessions |
| IntelliCare - Low Engager, Coaching | App Engagement From App Sessions | Week 1 | 7 app sessions |
| IntelliCare - Low Engager, Coaching | App Engagement From App Sessions | Week 2 | 4.5 app sessions |
| Patient Education | App Engagement From App Sessions | Week 3 | 0 app sessions |
| Patient Education | App Engagement From App Sessions | Week 4 | 0 app sessions |
| Patient Education | App Engagement From App Sessions | Week 2 | 0 app sessions |
| Patient Education | App Engagement From App Sessions | Week 1 | 2 app sessions |
| Patient Education | App Engagement From App Sessions | Week 5 | 0 app sessions |
| Patient Education | App Engagement From App Sessions | Week 8 | 0 app sessions |
| Patient Education | App Engagement From App Sessions | Week 7 | 0 app sessions |
| Patient Education | App Engagement From App Sessions | Week 6 | 0 app sessions |
Secondary
Multidimensional Fatigue Symptom Inventory-Short Form
Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Multidimensional Fatigue Symptom Inventory-Short Form | 19.7 score on a scale | Standard Deviation 22.7 |
| IntelliCare - Low Engager, No Coaching | Multidimensional Fatigue Symptom Inventory-Short Form | 24.0 score on a scale | Standard Deviation 18.1 |
| IntelliCare - Low Engager, Coaching | Multidimensional Fatigue Symptom Inventory-Short Form | 20.5 score on a scale | Standard Deviation 22.2 |
| Patient Education | Multidimensional Fatigue Symptom Inventory-Short Form | 25.8 score on a scale | Standard Deviation 23.2 |
Secondary
Multidimensional Fatigue Symptom Inventory-Short Form
Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Multidimensional Fatigue Symptom Inventory-Short Form | 35.4 score on a scale | Standard Deviation 19.5 |
| IntelliCare - Low Engager, No Coaching | Multidimensional Fatigue Symptom Inventory-Short Form | 38.8 score on a scale | Standard Deviation 16.4 |
| IntelliCare - Low Engager, Coaching | Multidimensional Fatigue Symptom Inventory-Short Form | 42.9 score on a scale | Standard Deviation 17.4 |
| Patient Education | Multidimensional Fatigue Symptom Inventory-Short Form | 42.0 score on a scale | Standard Deviation 19.8 |
Secondary
Multidimensional Fatigue Symptom Inventory-Short Form
Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Multidimensional Fatigue Symptom Inventory-Short Form | 25.3 score on a scale | Standard Deviation 20.1 |
| IntelliCare - Low Engager, No Coaching | Multidimensional Fatigue Symptom Inventory-Short Form | 29.5 score on a scale | Standard Deviation 19.3 |
| IntelliCare - Low Engager, Coaching | Multidimensional Fatigue Symptom Inventory-Short Form | 27.2 score on a scale | Standard Deviation 20.1 |
| Patient Education | Multidimensional Fatigue Symptom Inventory-Short Form | 31.3 score on a scale | Standard Deviation 22.5 |
Secondary
Multidimensional Fatigue Symptom Inventory-Short Form
Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Multidimensional Fatigue Symptom Inventory-Short Form | 21.1 score on a scale | Standard Deviation 21.1 |
| IntelliCare - Low Engager, No Coaching | Multidimensional Fatigue Symptom Inventory-Short Form | 26.8 score on a scale | Standard Deviation 19.2 |
| IntelliCare - Low Engager, Coaching | Multidimensional Fatigue Symptom Inventory-Short Form | 24.6 score on a scale | Standard Deviation 19.4 |
| Patient Education | Multidimensional Fatigue Symptom Inventory-Short Form | 29.5 score on a scale | Standard Deviation 24.3 |
Secondary
Penn State Worry Questionnaire
The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Penn State Worry Questionnaire | 56.8 score on a scale | Standard Deviation 12.7 |
| IntelliCare - Low Engager, No Coaching | Penn State Worry Questionnaire | 57.8 score on a scale | Standard Deviation 13.7 |
| IntelliCare - Low Engager, Coaching | Penn State Worry Questionnaire | 61.3 score on a scale | Standard Deviation 14.1 |
| Patient Education | Penn State Worry Questionnaire | 59.5 score on a scale | Standard Deviation 12.7 |
Secondary
Penn State Worry Questionnaire
The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Penn State Worry Questionnaire | 53.1 score on a scale | Standard Deviation 12.9 |
| IntelliCare - Low Engager, No Coaching | Penn State Worry Questionnaire | 54.0 score on a scale | Standard Deviation 12.8 |
| IntelliCare - Low Engager, Coaching | Penn State Worry Questionnaire | 54.2 score on a scale | Standard Deviation 14.3 |
| Patient Education | Penn State Worry Questionnaire | 55.0 score on a scale | Standard Deviation 12.4 |
Secondary
Penn State Worry Questionnaire
The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Penn State Worry Questionnaire | 50.1 score on a scale | Standard Deviation 13.9 |
| IntelliCare - Low Engager, No Coaching | Penn State Worry Questionnaire | 50.8 score on a scale | Standard Deviation 10.2 |
| IntelliCare - Low Engager, Coaching | Penn State Worry Questionnaire | 55.9 score on a scale | Standard Deviation 15.5 |
| Patient Education | Penn State Worry Questionnaire | 55.0 score on a scale | Standard Deviation 13.5 |
Secondary
Penn State Worry Questionnaire
The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Penn State Worry Questionnaire | 48.8 score on a scale | Standard Deviation 13 |
| IntelliCare - Low Engager, No Coaching | Penn State Worry Questionnaire | 49.4 score on a scale | Standard Deviation 12.3 |
| IntelliCare - Low Engager, Coaching | Penn State Worry Questionnaire | 51.9 score on a scale | Standard Deviation 14.6 |
| Patient Education | Penn State Worry Questionnaire | 54.4 score on a scale | Standard Deviation 14.4 |
Secondary
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Pittsburgh Sleep Quality Index | 8.7 score on a scale | Standard Deviation 4 |
| IntelliCare - Low Engager, No Coaching | Pittsburgh Sleep Quality Index | 9.6 score on a scale | Standard Deviation 3.6 |
| IntelliCare - Low Engager, Coaching | Pittsburgh Sleep Quality Index | 8.0 score on a scale | Standard Deviation 3.5 |
| Patient Education | Pittsburgh Sleep Quality Index | 9.5 score on a scale | Standard Deviation 4.2 |
Secondary
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Pittsburgh Sleep Quality Index | 10.7 score on a scale | Standard Deviation 4.1 |
| IntelliCare - Low Engager, No Coaching | Pittsburgh Sleep Quality Index | 10.8 score on a scale | Standard Deviation 3.5 |
| IntelliCare - Low Engager, Coaching | Pittsburgh Sleep Quality Index | 10.2 score on a scale | Standard Deviation 4 |
| Patient Education | Pittsburgh Sleep Quality Index | 11.1 score on a scale | Standard Deviation 4.3 |
Secondary
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Pittsburgh Sleep Quality Index | 9.8 score on a scale | Standard Deviation 4 |
| IntelliCare - Low Engager, No Coaching | Pittsburgh Sleep Quality Index | 9.3 score on a scale | Standard Deviation 3.4 |
| IntelliCare - Low Engager, Coaching | Pittsburgh Sleep Quality Index | 8.5 score on a scale | Standard Deviation 4.2 |
| Patient Education | Pittsburgh Sleep Quality Index | 9.9 score on a scale | Standard Deviation 4.3 |
Secondary
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Pittsburgh Sleep Quality Index | 8.9 score on a scale | Standard Deviation 3.8 |
| IntelliCare - Low Engager, No Coaching | Pittsburgh Sleep Quality Index | 10.1 score on a scale | Standard Deviation 3.5 |
| IntelliCare - Low Engager, Coaching | Pittsburgh Sleep Quality Index | 8.5 score on a scale | Standard Deviation 4 |
| Patient Education | Pittsburgh Sleep Quality Index | 9.8 score on a scale | Standard Deviation 4.6 |
Secondary
PROMIS Global Mental Health v1.2
The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | PROMIS Global Mental Health v1.2 | 39.5 T-score | Standard Deviation 6.3 |
| IntelliCare - Low Engager, No Coaching | PROMIS Global Mental Health v1.2 | 38.8 T-score | Standard Deviation 6.1 |
| IntelliCare - Low Engager, Coaching | PROMIS Global Mental Health v1.2 | 37.6 T-score | Standard Deviation 5.6 |
| Patient Education | PROMIS Global Mental Health v1.2 | 38.4 T-score | Standard Deviation 7 |
Secondary
PROMIS Global Mental Health v1.2
The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | PROMIS Global Mental Health v1.2 | 45.5 T-score | Standard Deviation 8.5 |
| IntelliCare - Low Engager, No Coaching | PROMIS Global Mental Health v1.2 | 45.2 T-score | Standard Deviation 6 |
| IntelliCare - Low Engager, Coaching | PROMIS Global Mental Health v1.2 | 44.8 T-score | Standard Deviation 6.6 |
| Patient Education | PROMIS Global Mental Health v1.2 | 42.6 T-score | Standard Deviation 8.3 |
Secondary
PROMIS Global Mental Health v1.2
The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | PROMIS Global Mental Health v1.2 | 45.2 T-score | Standard Deviation 8.6 |
| IntelliCare - Low Engager, No Coaching | PROMIS Global Mental Health v1.2 | 43.7 T-score | Standard Deviation 6.6 |
| IntelliCare - Low Engager, Coaching | PROMIS Global Mental Health v1.2 | 43.0 T-score | Standard Deviation 6.6 |
| Patient Education | PROMIS Global Mental Health v1.2 | 41.4 T-score | Standard Deviation 7.9 |
Secondary
PROMIS Global Mental Health v1.2
The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | PROMIS Global Mental Health v1.2 | 42.6 T-score | Standard Deviation 7.1 |
| IntelliCare - Low Engager, No Coaching | PROMIS Global Mental Health v1.2 | 41.5 T-score | Standard Deviation 6 |
| IntelliCare - Low Engager, Coaching | PROMIS Global Mental Health v1.2 | 42.4 T-score | Standard Deviation 5.6 |
| Patient Education | PROMIS Global Mental Health v1.2 | 40.3 T-score | Standard Deviation 7 |
Secondary
PROMIS Satisfaction With Sex Life
The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | PROMIS Satisfaction With Sex Life | 10.6 score on a scale | Standard Deviation 6.1 |
| IntelliCare - Low Engager, No Coaching | PROMIS Satisfaction With Sex Life | 10.4 score on a scale | Standard Deviation 6 |
| IntelliCare - Low Engager, Coaching | PROMIS Satisfaction With Sex Life | 12.0 score on a scale | Standard Deviation 6.5 |
| Patient Education | PROMIS Satisfaction With Sex Life | 10.5 score on a scale | Standard Deviation 5.9 |
Secondary
PROMIS Satisfaction With Sex Life
The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | PROMIS Satisfaction With Sex Life | 10.5 score on a scale | Standard Deviation 5.9 |
| IntelliCare - Low Engager, No Coaching | PROMIS Satisfaction With Sex Life | 9.7 score on a scale | Standard Deviation 5.6 |
| IntelliCare - Low Engager, Coaching | PROMIS Satisfaction With Sex Life | 11.6 score on a scale | Standard Deviation 5.9 |
| Patient Education | PROMIS Satisfaction With Sex Life | 10.2 score on a scale | Standard Deviation 5.7 |
Secondary
PROMIS Satisfaction With Sex Life
The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | PROMIS Satisfaction With Sex Life | 9.4 score on a scale | Standard Deviation 5 |
| IntelliCare - Low Engager, No Coaching | PROMIS Satisfaction With Sex Life | 8.9 score on a scale | Standard Deviation 4.6 |
| IntelliCare - Low Engager, Coaching | PROMIS Satisfaction With Sex Life | 10.6 score on a scale | Standard Deviation 6.5 |
| Patient Education | PROMIS Satisfaction With Sex Life | 9.2 score on a scale | Standard Deviation 5 |
Secondary
PROMIS Satisfaction With Sex Life
The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | PROMIS Satisfaction With Sex Life | 9.3 score on a scale | Standard Deviation 5.1 |
| IntelliCare - Low Engager, No Coaching | PROMIS Satisfaction With Sex Life | 9.1 score on a scale | Standard Deviation 5.1 |
| IntelliCare - Low Engager, Coaching | PROMIS Satisfaction With Sex Life | 11.7 score on a scale | Standard Deviation 6.3 |
| Patient Education | PROMIS Satisfaction With Sex Life | 9.9 score on a scale | Standard Deviation 5.1 |
Secondary
Ten Item Personality Inventory - Agreeableness
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Agreeableness | 11.2 score on a scale | Standard Deviation 2.5 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Agreeableness | 10.7 score on a scale | Standard Deviation 2.2 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Agreeableness | 10.6 score on a scale | Standard Deviation 2.3 |
| Patient Education | Ten Item Personality Inventory - Agreeableness | 11.0 score on a scale | Standard Deviation 2.3 |
Secondary
Ten Item Personality Inventory - Agreeableness
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Agreeableness | 11.2 score on a scale | Standard Deviation 2.3 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Agreeableness | 10.8 score on a scale | Standard Deviation 2.2 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Agreeableness | 11.1 score on a scale | Standard Deviation 2.1 |
| Patient Education | Ten Item Personality Inventory - Agreeableness | 10.7 score on a scale | Standard Deviation 2.5 |
Secondary
Ten Item Personality Inventory - Agreeableness
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Agreeableness | 10.9 score on a scale | Standard Deviation 2.2 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Agreeableness | 10.2 score on a scale | Standard Deviation 2.3 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Agreeableness | 10.3 score on a scale | Standard Deviation 2 |
| Patient Education | Ten Item Personality Inventory - Agreeableness | 10.2 score on a scale | Standard Deviation 2.6 |
Secondary
Ten Item Personality Inventory - Agreeableness
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Agreeableness | 11.1 score on a scale | Standard Deviation 2.3 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Agreeableness | 10.9 score on a scale | Standard Deviation 2.3 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Agreeableness | 11.0 score on a scale | Standard Deviation 2.4 |
| Patient Education | Ten Item Personality Inventory - Agreeableness | 10.7 score on a scale | Standard Deviation 2.6 |
Secondary
Ten Item Personality Inventory - Conscientiousness
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Conscientiousness | 11.0 score on a scale | Standard Deviation 2.6 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Conscientiousness | 10.8 score on a scale | Standard Deviation 2.6 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Conscientiousness | 10.5 score on a scale | Standard Deviation 2.6 |
| Patient Education | Ten Item Personality Inventory - Conscientiousness | 10.9 score on a scale | Standard Deviation 2.6 |
Secondary
Ten Item Personality Inventory - Conscientiousness
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Conscientiousness | 11.2 score on a scale | Standard Deviation 2.2 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Conscientiousness | 10.4 score on a scale | Standard Deviation 3 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Conscientiousness | 11.0 score on a scale | Standard Deviation 2.8 |
| Patient Education | Ten Item Personality Inventory - Conscientiousness | 10.7 score on a scale | Standard Deviation 2.7 |
Secondary
Ten Item Personality Inventory - Conscientiousness
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Conscientiousness | 11.3 score on a scale | Standard Deviation 2.5 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Conscientiousness | 10.8 score on a scale | Standard Deviation 2.7 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Conscientiousness | 10.9 score on a scale | Standard Deviation 2.7 |
| Patient Education | Ten Item Personality Inventory - Conscientiousness | 10.7 score on a scale | Standard Deviation 2.7 |
Secondary
Ten Item Personality Inventory - Conscientiousness
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Conscientiousness | 11.2 score on a scale | Standard Deviation 2.4 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Conscientiousness | 11.0 score on a scale | Standard Deviation 2.7 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Conscientiousness | 10.0 score on a scale | Standard Deviation 2.8 |
| Patient Education | Ten Item Personality Inventory - Conscientiousness | 11.1 score on a scale | Standard Deviation 2.5 |
Secondary
Ten Item Personality Inventory - Extraversion
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Extraversion | 8.3 score on a scale | Standard Deviation 3.1 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Extraversion | 7.9 score on a scale | Standard Deviation 3.2 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Extraversion | 8.8 score on a scale | Standard Deviation 3.5 |
| Patient Education | Ten Item Personality Inventory - Extraversion | 8.0 score on a scale | Standard Deviation 3.3 |
Secondary
Ten Item Personality Inventory - Extraversion
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Extraversion | 8.1 score on a scale | Standard Deviation 3.2 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Extraversion | 8.2 score on a scale | Standard Deviation 3.4 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Extraversion | 8.7 score on a scale | Standard Deviation 3.9 |
| Patient Education | Ten Item Personality Inventory - Extraversion | 7.3 score on a scale | Standard Deviation 3.3 |
Secondary
Ten Item Personality Inventory - Extraversion
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Extraversion | 8.2 score on a scale | Standard Deviation 3.3 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Extraversion | 8.1 score on a scale | Standard Deviation 3.3 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Extraversion | 8.4 score on a scale | Standard Deviation 3.2 |
| Patient Education | Ten Item Personality Inventory - Extraversion | 7.8 score on a scale | Standard Deviation 3.1 |
Secondary
Ten Item Personality Inventory- Extraversion
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory- Extraversion | 8.0 score on a scale | Standard Deviation 3.5 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory- Extraversion | 8.1 score on a scale | Standard Deviation 3.5 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory- Extraversion | 8.8 score on a scale | Standard Deviation 3.7 |
| Patient Education | Ten Item Personality Inventory- Extraversion | 7.4 score on a scale | Standard Deviation 3.3 |
Secondary
Ten Item Personality Inventory - Neuroticism
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Neuroticism | 8.5 score on a scale | Standard Deviation 2.7 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Neuroticism | 8.5 score on a scale | Standard Deviation 2.5 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Neuroticism | 8.3 score on a scale | Standard Deviation 2.8 |
| Patient Education | Ten Item Personality Inventory - Neuroticism | 7.9 score on a scale | Standard Deviation 2.8 |
Secondary
Ten Item Personality Inventory - Neuroticism
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Neuroticism | 9.5 score on a scale | Standard Deviation 2.7 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Neuroticism | 8.9 score on a scale | Standard Deviation 2.6 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Neuroticism | 8.3 score on a scale | Standard Deviation 2.8 |
| Patient Education | Ten Item Personality Inventory - Neuroticism | 8.4 score on a scale | Standard Deviation 2.9 |
Secondary
Ten Item Personality Inventory - Neuroticism
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Neuroticism | 8.9 score on a scale | Standard Deviation 3 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Neuroticism | 8.5 score on a scale | Standard Deviation 2.5 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Neuroticism | 8.4 score on a scale | Standard Deviation 2.5 |
| Patient Education | Ten Item Personality Inventory - Neuroticism | 8.2 score on a scale | Standard Deviation 2.8 |
Secondary
Ten Item Personality Inventory - Neuroticism
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Neuroticism | 7.6 score on a scale | Standard Deviation 2.7 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Neuroticism | 7.7 score on a scale | Standard Deviation 2.6 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Neuroticism | 6.6 score on a scale | Standard Deviation 2.7 |
| Patient Education | Ten Item Personality Inventory - Neuroticism | 7.3 score on a scale | Standard Deviation 2.8 |
Secondary
Ten Item Personality Inventory - Openness
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Openness | 10.4 score on a scale | Standard Deviation 2.4 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Openness | 10.0 score on a scale | Standard Deviation 2.6 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Openness | 10.2 score on a scale | Standard Deviation 2.5 |
| Patient Education | Ten Item Personality Inventory - Openness | 10.2 score on a scale | Standard Deviation 2.7 |
Secondary
Ten Item Personality Inventory - Openness
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Openness | 10.1 score on a scale | Standard Deviation 2.5 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Openness | 9.7 score on a scale | Standard Deviation 2.3 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Openness | 10.8 score on a scale | Standard Deviation 2 |
| Patient Education | Ten Item Personality Inventory - Openness | 9.6 score on a scale | Standard Deviation 2.5 |
Secondary
Ten Item Personality Inventory - Openness
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Openness | 10.2 score on a scale | Standard Deviation 2.3 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Openness | 10.2 score on a scale | Standard Deviation 2.5 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Openness | 10.5 score on a scale | Standard Deviation 2 |
| Patient Education | Ten Item Personality Inventory - Openness | 9.6 score on a scale | Standard Deviation 2.7 |
Secondary
Ten Item Personality Inventory - Openness
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Ten Item Personality Inventory - Openness | 10.2 score on a scale | Standard Deviation 2.5 |
| IntelliCare - Low Engager, No Coaching | Ten Item Personality Inventory - Openness | 10.6 score on a scale | Standard Deviation 2.7 |
| IntelliCare - Low Engager, Coaching | Ten Item Personality Inventory - Openness | 10.5 score on a scale | Standard Deviation 2.1 |
| Patient Education | Ten Item Personality Inventory - Openness | 10.2 score on a scale | Standard Deviation 2.3 |
Secondary
TWente Engagement With Ehealth Technologies Scale (TWEETS)
The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains.
Time frame: Baseline
Population: This measure was not administered because it was deemed to be redundant with the other intervention engagement and adherence measures. It was omitted to reduce participant burden.
Secondary
TWente Engagement With Ehealth Technologies Scale (TWEETS)
The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains.
Time frame: 6 months
Population: This measure was not administered because it was deemed to be redundant with the other intervention engagement and adherence measures. It was omitted to reduce participant burden.
Secondary
TWente Engagement With Ehealth Technologies Scale (TWEETS)
The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains.
Time frame: 12 months
Population: This measure was not administered because it was deemed to be redundant with the other intervention engagement and adherence measures. It was omitted to reduce participant burden.
Secondary
TWente Engagement With Ehealth Technologies Scale (TWEETS)
The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains.
Time frame: 8 weeks
Population: This measure was not administered because it was deemed to be redundant with the other intervention engagement and adherence measures. It was omitted to reduce participant burden.
Secondary
UAMS Health Literacy Measure
The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | UAMS Health Literacy Measure | 10.5 score on a scale | Standard Deviation 1.1 |
| IntelliCare - Low Engager, No Coaching | UAMS Health Literacy Measure | 10.7 score on a scale | Standard Deviation 1 |
| IntelliCare - Low Engager, Coaching | UAMS Health Literacy Measure | 10.7 score on a scale | Standard Deviation 0.8 |
| Patient Education | UAMS Health Literacy Measure | 10.7 score on a scale | Standard Deviation 1.2 |
Secondary
UAMS Health Literacy Measure
The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | UAMS Health Literacy Measure | 10.3 score on a scale | Standard Deviation 1.2 |
| IntelliCare - Low Engager, No Coaching | UAMS Health Literacy Measure | 10.7 score on a scale | Standard Deviation 1 |
| IntelliCare - Low Engager, Coaching | UAMS Health Literacy Measure | 10.3 score on a scale | Standard Deviation 1.3 |
| Patient Education | UAMS Health Literacy Measure | 10.4 score on a scale | Standard Deviation 1.1 |
Secondary
UAMS Health Literacy Measure
The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | UAMS Health Literacy Measure | 10.6 score on a scale | Standard Deviation 1.1 |
| IntelliCare - Low Engager, No Coaching | UAMS Health Literacy Measure | 10.6 score on a scale | Standard Deviation 0.8 |
| IntelliCare - Low Engager, Coaching | UAMS Health Literacy Measure | 10.4 score on a scale | Standard Deviation 1.2 |
| Patient Education | UAMS Health Literacy Measure | 10.7 score on a scale | Standard Deviation 0.9 |
Secondary
UAMS Health Literacy Measure
The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | UAMS Health Literacy Measure | 10.5 score on a scale | Standard Deviation 1.1 |
| IntelliCare - Low Engager, No Coaching | UAMS Health Literacy Measure | 10.4 score on a scale | Standard Deviation 1.3 |
| IntelliCare - Low Engager, Coaching | UAMS Health Literacy Measure | 10.0 score on a scale | Standard Deviation 1.7 |
| Patient Education | UAMS Health Literacy Measure | 10.5 score on a scale | Standard Deviation 1.2 |
Other Pre-specified
Digital Intervention Adherence Questionnaire
A 26 item questionnaire that assesses perceived adherence to a digital intervention due to barriers to use. Each item is scored on a 0 (not at all) to 2 (very) scale and the items are summed to compute a total score ranging from 0-52. Higher scores indicate lower perceived adherence to a digital intervention due to barriers to use.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Digital Intervention Adherence Questionnaire | 7.6 score on a scale | Standard Deviation 7.1 |
| IntelliCare - Low Engager, No Coaching | Digital Intervention Adherence Questionnaire | 10.6 score on a scale | Standard Deviation 9.3 |
| IntelliCare - Low Engager, Coaching | Digital Intervention Adherence Questionnaire | 7.3 score on a scale | Standard Deviation 6 |
| Patient Education | Digital Intervention Adherence Questionnaire | 5.1 score on a scale | Standard Deviation 5.9 |
Other Pre-specified
Digital Intervention Evaluation Questionnaire
A 12-item questionnaire with subscales of perceived utility and perceived impact of digital interventions. Each item is rated on a 0 (not at all) to 5 (very) scale and the items are summed to compute a total score ranging from 0-60. Higher scores indicate higher perceived utility and impact of a digital intervention.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Digital Intervention Evaluation Questionnaire | 27.8 score on a scale | Standard Deviation 10.5 |
| IntelliCare - Low Engager, No Coaching | Digital Intervention Evaluation Questionnaire | 25.7 score on a scale | Standard Deviation 10.4 |
| IntelliCare - Low Engager, Coaching | Digital Intervention Evaluation Questionnaire | 30.4 score on a scale | Standard Deviation 9.7 |
| Patient Education | Digital Intervention Evaluation Questionnaire | 23.5 score on a scale | Standard Deviation 10.7 |
Post Hoc
Limited List of Questions for Exit Interview
The purpose of collecting this data was to explore how the intervention could be improved upon in future trials. Only those that receive the IntelliCare apps will be administered a qualitative interview that contains items assessing how the app intervention met their needs as a breast cancer survivor and possible changes to improve fit. Study staff will administer this interview on the phone and manually type in the participant responses during the interview. 10 questions will assess overall impressions of the IntelliCare app program to inform how it could be improved upon for future trials. When new data no longer adds new information or a new theme to the analysis, the theme is considered sufficiently explored and important. A numerical threshold for theme importance in qualitative analysis is not important, as this can lead to losing valuable, nuanced insights.
Time frame: 8 weeks
Population: The data collected were qualitative based on interviews with participants who received IntelliCare. The Patient Education participants did not receive the Intellicare App. The count of participants that endorsed each theme is provided, however, it is important to stress that the goal was to identify meaningful patterns and concepts within the data, not just count how many people mention a theme.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IntelliCare - High Engager, No Coaching | Limited List of Questions for Exit Interview | Have a way for users to connect with one another directly to provide emotional support | 8 Participants |
| IntelliCare - High Engager, No Coaching | Limited List of Questions for Exit Interview | Make loading pictures easier | 2 Participants |
| IntelliCare - High Engager, No Coaching | Limited List of Questions for Exit Interview | Include cancer related examples in the activities in the app to make them more relatable | 17 Participants |
| IntelliCare - High Engager, No Coaching | Limited List of Questions for Exit Interview | More variety of activities in the behavioral activation portion of the intervention | 3 Participants |
| IntelliCare - High Engager, No Coaching | Limited List of Questions for Exit Interview | Want more variety of activities and exercises to choose from to learn additional skills | 10 Participants |
| IntelliCare - High Engager, No Coaching | Limited List of Questions for Exit Interview | Create a progress report for users as they use the app over time | 4 Participants |
| IntelliCare - Low Engager, No Coaching | Limited List of Questions for Exit Interview | Want more variety of activities and exercises to choose from to learn additional skills | 6 Participants |
| IntelliCare - Low Engager, No Coaching | Limited List of Questions for Exit Interview | More variety of activities in the behavioral activation portion of the intervention | 4 Participants |
| IntelliCare - Low Engager, No Coaching | Limited List of Questions for Exit Interview | Create a progress report for users as they use the app over time | 1 Participants |
| IntelliCare - Low Engager, No Coaching | Limited List of Questions for Exit Interview | Have a way for users to connect with one another directly to provide emotional support | 1 Participants |
| IntelliCare - Low Engager, No Coaching | Limited List of Questions for Exit Interview | Make loading pictures easier | 3 Participants |
| IntelliCare - Low Engager, No Coaching | Limited List of Questions for Exit Interview | Include cancer related examples in the activities in the app to make them more relatable | 8 Participants |
| IntelliCare - Low Engager, Coaching | Limited List of Questions for Exit Interview | Want more variety of activities and exercises to choose from to learn additional skills | 3 Participants |
| IntelliCare - Low Engager, Coaching | Limited List of Questions for Exit Interview | Include cancer related examples in the activities in the app to make them more relatable | 9 Participants |
| IntelliCare - Low Engager, Coaching | Limited List of Questions for Exit Interview | Have a way for users to connect with one another directly to provide emotional support | 0 Participants |
| IntelliCare - Low Engager, Coaching | Limited List of Questions for Exit Interview | Create a progress report for users as they use the app over time | 0 Participants |
| IntelliCare - Low Engager, Coaching | Limited List of Questions for Exit Interview | More variety of activities in the behavioral activation portion of the intervention | 4 Participants |
| IntelliCare - Low Engager, Coaching | Limited List of Questions for Exit Interview | Make loading pictures easier | 3 Participants |
| Patient Education | Limited List of Questions for Exit Interview | Want more variety of activities and exercises to choose from to learn additional skills | 0 Participants |
| Patient Education | Limited List of Questions for Exit Interview | Have a way for users to connect with one another directly to provide emotional support | 0 Participants |
| Patient Education | Limited List of Questions for Exit Interview | Create a progress report for users as they use the app over time | 0 Participants |
| Patient Education | Limited List of Questions for Exit Interview | Make loading pictures easier | 0 Participants |
| Patient Education | Limited List of Questions for Exit Interview | Include cancer related examples in the activities in the app to make them more relatable | 0 Participants |
| Patient Education | Limited List of Questions for Exit Interview | More variety of activities in the behavioral activation portion of the intervention | 0 Participants |