HIV (Human Immunodeficiency Virus)
Conditions
Keywords
HIV, Health Management App, HIV symptoms
Brief summary
The goal of this study is to facilitate the dissemination and implementation of patient centered outcomes research using mHealth technology to improve self-management of adverse symptoms in persons living with HIV/AIDS (PLWH). Symptom management in PLWH is especially important because the US HIV epidemic continues to exact a huge toll, especially among Agency for Healthcare Research and Quality (AHRQ) priority populations including racial, ethnic, and sexual minorities and low-income persons. The incorporation of HIV symptom management strategies into patients' lives through the use of mHealth technologies has the potential to advance the effective dissemination and implementation of patient centered outcomes research findings.
Detailed description
HIV has changed from an acute illness to a chronic disease. The success of HIV medications and treatments has significantly altered the course of the disease. While AIDS-related illnesses are no longer the primary threat, a new set of HIV-associated complications have emerged, resulting in a chronic disease that for many will span several decades of life. The ability to self-manage adverse symptoms of HIV illness has been shown to improve patient-centered outcomes. In response to this need, a team at University of California, San Francisco (UCSF) developed a paper-based symptom management manual with self-management strategies for 21 common HIV/AIDS adverse symptoms (PCOR evidence). The efficacy of the manual was demonstrated in a 775-person randomized controlled trial (RCT) over three months at 12 sites. However, subsequent use of these strategies has been very limited; mHealth offers an ideal platform for the implementation and dissemination of evidence-based strategies for HIV symptom management. Due to the high incidence of HIV among racial and ethnic minority populations, it is appropriate to develop mHealth tools tailored to the needs of these populations. mHealth technology has the potential to address many of the healthcare needs of persons living with HIV/AIDS (PLWH) including symptom management. In response to these current issues, this study seeks to inform the development and testing of a mHealth application that will incorporate findings from PCOR studies to improve the outcomes of PLWH. To improve outcomes for those most in need, study activities are focused on communities with the greatest burden of HIV in the US, including racial and ethnic minorities and those of low socioeconomic status.
Interventions
DEVICEHealth Management App with symptom strategies
The mVIP group will receive a Health Management App with symptom strategies. A mobile app which includes symptom strategies from the UCSF symptom management manual.
DEVICEControl App
The attention control group will receive an app which asked them about their symptoms but did not provide symptoms strategies
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with HIV/AIDS 2. Over the age of 18 years 3. Able to provide written informed consent 4. Able to communicate in English 5. Health literacy level of marginal or inadequate (as measured by the Newest Vital Sign (NVS): total score of 3 or lower) 6. Report at least 2 HIV related adverse symptoms in the past week 7. Owner of a smart phone/tablet.
Exclusion criteria
1. Inability to communicate in English 2. Documented diagnosis of dementia 3. Pregnancy 4. Unable to understand consent procedure 5. Self-reporting no adverse symptoms within the past week. (HIV-related symptoms include: anxiety, constipation, cough, depression, diarrhea, dizziness, fever, forgetfulness, fatigue, nausea, night sweats, neuropathy, shortness of breath, dermatitis, swelling of arms, hand, legs, feet, insomnia, weight loss, oral thrush, and vaginal itching, burning and discharge)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptom Status From Baseline to Week 12 | Baseline and 12 weeks | Change in Symptom Status calculates the difference in symptom scores between the intervention and control groups at baseline versus follow-up after 12 weeks. Symptom scores were determined using the Revised Sign and Symptom Check-List for HIV (SSC-HIVrev), where participants who reported experiencing any one of the 13 symptoms in the past 7 days were asked how much it bothered them (a little bit, somewhat, quite a bit, or very much). Instances where the symptom did not bother the individual were coded as 0 whereas instances where the symptom bothered the individual any amount were recoded as 1. The overall difference between groups at baseline and after 12 weeks (difference of differences) falls within a range of -1 to 1, where lower numbers indicate the symptom bothered the person less, while higher numbers indicate it bothered them more. With the Difference Between Groups, a more negative score (closer to -1) represents a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life -- RAND-36 | Baseline and 12 weeks | 36-Item Short Form Survey (RAND-36) is a widely-used 36-item tool to measure health-related quality of life, where each item in the scale is scored as 0, 25, 50, 75, or 100. Scoring is a two-step process. First, precoded numeric values are recoded per the scoring key so that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores, where a lower score may indicate a better outcome for some of the scales, while it may indicate a better outcome for others. |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | 12 weeks | The PROMIS-29 includes seven health related quality of life domains on a 5-point scale from a score of 1 to 5 and the pain domain has two subdomains (interference and intensity) where pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain (10). Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. T-scores can be estimated using the scoring tables listed in the PROMIS manuals. A higher PROMIS T-score implies more of the concept being measured; for instance, a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates a greater severity of depression. |
| Engagement With Healthcare Provider | Baseline and 12 weeks | Engagement with Health Care Provide scale is a 13-item scale in which subjects rate their interactions with their health care providers on a four-point scale with 1=always true and 4=never true in which a lower score indicates a better outcome. The scores are then collated to an aggregate score where the minimum value = 13 and the maximum value = 52. A low score indicates greater provider engagement, where as higher scores indicate lower provider engagement (less favorable outcome). The difference in scores at baseline and follow-up at three months was calculated within both the intervention and control groups, and the difference was then taken between the resulting means of those scores. |
| Medication Adherence | 12 weeks | Medication adherence was calculated by two scales: the Center for Adherence Support Evaluation (CASE) Adherence Index and the Visual Analogue Scale (VAS). The CASE Adherence Index consists of the composite scores of three questions evaluating self-reported measures of adherence. The minimum score on this scale is 3 while the maximum score on this scale is 16, with higher scores indicating better outcome. Scores greater than 10 indicate good adherence, while scores less than or equal to 10 indicate poor adherence. The VAS asks subjects to indicate a point on a line that shows their best guess about how much of each drug they have taken from a scale of 0% to 100% in which 0% means they have taken no drug, 50% means they have taken half their drugs, and 100% means they have taken every single dose. Consequently, a higher score (100%) indicates |
| Health-IT Usability Evaluation Scale (Health-ITUES) | 12 weeks | Health Information Technology Usability Evaluation Scale (Health-ITUES) was used to measure usability. Health-ITUES consists of 20 items rated on a 5-point Likert scale from strongly disagree (score of 1) to strongly agree (score of 5) measuring actual usage, intention to use, satisfaction, perceived usefulness, perceived ease of use, perceived performance speed, learnability, competency, flexibility/customizability, memorability, error prevention, information needs, and other outcomes. A higher score (5) indicates higher usability. Overall score was calculated as the mean score from the score for quality of life, perceived usefulness, perceived ease of use, and user control. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| mVIP Group This group will receive targeted symptom strategies from the UCSF symptom management manual based on the symptoms that they report.
Health Management App with symptom strategies: The mVIP group will receive a Health Management App with symptom strategies. A mobile app which includes symptom strategies from the UCSF symptom management manual. | 40 |
| Attention Control Group This group will have the Health Management App without symptom strategies pre-loaded on their smartphones.
Health Management App without symptom strategies: The attention control group will receive the Health Management App preloaded on their smartphones without symptoms strategies | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Attention Control Group | Total | mVIP Group |
|---|---|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 9 | 50.4 years STANDARD_DEVIATION 10.4 | 50 years STANDARD_DEVIATION 11.7 |
| Annual income $10,000-$19,999/year | 10 Participants | 19 Participants | 9 Participants |
| Annual income $20,000-$59,999/year | 8 Participants | 11 Participants | 3 Participants |
| Annual income Don't know or prefer not to answer | 5 Participants | 11 Participants | 6 Participants |
| Annual income Less than $10,000/year | 17 Participants | 39 Participants | 22 Participants |
| Antiretroviral therapy (ART) Use 1 pill per day | 20 Participants | 41 Participants | 21 Participants |
| Antiretroviral therapy (ART) Use 2+ pills per day | 19 Participants | 34 Participants | 15 Participants |
| Antiretroviral therapy (ART) Use None | 1 Participants | 4 Participants | 3 Participants |
| Antiretroviral therapy (ART) Use Prefer not to answer | 0 Participants | 1 Participants | 1 Participants |
| Cluster of Differentiation 4 (CD4) count greater than 500 | 20 Participants | 42 Participants | 22 Participants |
| Education Bachelors or advanced degree | 8 Participants | 13 Participants | 5 Participants |
| Education High school | 14 Participants | 25 Participants | 11 Participants |
| Education Less than high school | 5 Participants | 14 Participants | 9 Participants |
| Education Some college or associates degree | 13 Participants | 28 Participants | 15 Participants |
| Employment Disabled | 16 Participants | 27 Participants | 11 Participants |
| Employment Retired | 1 Participants | 4 Participants | 3 Participants |
| Employment Student | 2 Participants | 4 Participants | 2 Participants |
| Employment Unemployed (looking, not looking) | 11 Participants | 26 Participants | 15 Participants |
| Employment Unspecified | 2 Participants | 4 Participants | 2 Participants |
| Employment Working (full, part, off-books) | 8 Participants | 15 Participants | 7 Participants |
| Ever diagnosed with AIDS | 24 Participants | 41 Participants | 17 Participants |
| Possible alcohol use disorder | 10 Participants | 25 Participants | 15 Participants |
| Race/Ethnicity, Customized Race Black, non-hispanic | 26 Participants | 55 Participants | 29 Participants |
| Race/Ethnicity, Customized Race Hispanic | 10 Participants | 17 Participants | 7 Participants |
| Race/Ethnicity, Customized Race White, non-hispanic | 4 Participants | 8 Participants | 4 Participants |
| Region of Enrollment United States | 40 participants | 80 participants | 40 participants |
| Sex: Female, Male Female | 17 Participants | 42 Participants | 25 Participants |
| Sex: Female, Male Male | 23 Participants | 38 Participants | 15 Participants |
| Substance use weekly or more often | 9 Participants | 24 Participants | 15 Participants |
| Virologically suppressed | 34 Participants | 68 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Change in Symptom Status From Baseline to Week 12
Change in Symptom Status calculates the difference in symptom scores between the intervention and control groups at baseline versus follow-up after 12 weeks. Symptom scores were determined using the Revised Sign and Symptom Check-List for HIV (SSC-HIVrev), where participants who reported experiencing any one of the 13 symptoms in the past 7 days were asked how much it bothered them (a little bit, somewhat, quite a bit, or very much). Instances where the symptom did not bother the individual were coded as 0 whereas instances where the symptom bothered the individual any amount were recoded as 1. The overall difference between groups at baseline and after 12 weeks (difference of differences) falls within a range of -1 to 1, where lower numbers indicate the symptom bothered the person less, while higher numbers indicate it bothered them more. With the Difference Between Groups, a more negative score (closer to -1) represents a better outcome.
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Symptom Status From Baseline to Week 12 | Skin problems | -0.219 score on a scale | Standard Error 0.091 |
| Intervention | Change in Symptom Status From Baseline to Week 12 | Fever, chills, sweats | -0.360 score on a scale | Standard Error 0.086 |
| Intervention | Change in Symptom Status From Baseline to Week 12 | Difficulty remembering | -0.343 score on a scale | Standard Error 0.095 |
| Intervention | Change in Symptom Status From Baseline to Week 12 | Depression | -0.540 score on a scale | Standard Error 0.106 |
| Intervention | Change in Symptom Status From Baseline to Week 12 | Fatigue | -0.566 score on a scale | Standard Error 0.115 |
| Intervention | Change in Symptom Status From Baseline to Week 12 | Dizziness | -0.319 score on a scale | Standard Error 0.083 |
| Intervention | Change in Symptom Status From Baseline to Week 12 | Anxiety | -0.858 score on a scale | Standard Error 0.102 |
| Intervention | Change in Symptom Status From Baseline to Week 12 | Cough of Shortness of Breath | -0.570 score on a scale | Standard Error 0.105 |
| Intervention | Change in Symptom Status From Baseline to Week 12 | Neuropathy | -0.713 score on a scale | Standard Error 0.103 |
| Intervention | Change in Symptom Status From Baseline to Week 12 | Diarrhea | -0.240 score on a scale | Standard Error 0.092 |
| Intervention | Change in Symptom Status From Baseline to Week 12 | Weight loss or wasting | -0.254 score on a scale | Standard Error 0.07 |
| Intervention | Change in Symptom Status From Baseline to Week 12 | Nausea or vomiting | -0.122 score on a scale | Standard Error 0.066 |
| Intervention | Change in Symptom Status From Baseline to Week 12 | Difficulty falling asleep | -0.506 score on a scale | Standard Error 0.106 |
| Control | Change in Symptom Status From Baseline to Week 12 | Dizziness | -0.181 score on a scale | Standard Error 0.095 |
| Control | Change in Symptom Status From Baseline to Week 12 | Anxiety | -0.318 score on a scale | Standard Error 0.118 |
| Control | Change in Symptom Status From Baseline to Week 12 | Cough of Shortness of Breath | -0.421 score on a scale | Standard Error 0.122 |
| Control | Change in Symptom Status From Baseline to Week 12 | Depression | -0.007 score on a scale | Standard Error 0.123 |
| Control | Change in Symptom Status From Baseline to Week 12 | Diarrhea | -0.233 score on a scale | Standard Error 0.107 |
| Control | Change in Symptom Status From Baseline to Week 12 | Difficulty falling asleep | -0.433 score on a scale | Standard Error 0.122 |
| Control | Change in Symptom Status From Baseline to Week 12 | Difficulty remembering | -0.169 score on a scale | Standard Error 0.11 |
| Control | Change in Symptom Status From Baseline to Week 12 | Fatigue | -0.563 score on a scale | Standard Error 0.132 |
| Control | Change in Symptom Status From Baseline to Week 12 | Fever, chills, sweats | -0.084 score on a scale | Standard Error 0.099 |
| Control | Change in Symptom Status From Baseline to Week 12 | Nausea or vomiting | -0.185 score on a scale | Standard Error 0.077 |
| Control | Change in Symptom Status From Baseline to Week 12 | Neuropathy | -0.228 score on a scale | Standard Error 0.119 |
| Control | Change in Symptom Status From Baseline to Week 12 | Skin problems | -0.089 score on a scale | Standard Error 0.105 |
| Control | Change in Symptom Status From Baseline to Week 12 | Weight loss or wasting | -0.004 score on a scale | Standard Error 0.081 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Fever, chills, sweats | -0.275 score on a scale | Standard Error 0.132 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Diarrhea | -0.007 score on a scale | Standard Error 0.141 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Skin problems | -0.130 score on a scale | Standard Error 0.139 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Nausea or vomiting | 0.063 score on a scale | Standard Error 0.101 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Depression | -0.533 score on a scale | Standard Error 0.163 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Anxiety | -0.541 score on a scale | Standard Error 0.156 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Neuropathy | -0.485 score on a scale | Standard Error 0.157 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Dizziness | -0.138 score on a scale | Standard Error 0.126 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Difficulty remembering | -0.174 score on a scale | Standard Error 0.145 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Cough of Shortness of Breath | -0.149 score on a scale | Standard Error 0.161 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Fatigue | -0.003 score on a scale | Standard Error 0.175 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Difficulty falling asleep | -0.073 score on a scale | Standard Error 0.162 |
| Difference Between Groups | Change in Symptom Status From Baseline to Week 12 | Weight loss or wasting | -0.250 score on a scale | Standard Error 0.107 |
Comparison: Anxietyp-value: 0.001Mixed Models Analysis
Comparison: Cough or Shortness of Breathp-value: 0.356Mixed Models Analysis
Comparison: Depressionp-value: 0.001Mixed Models Analysis
Comparison: Diarrheap-value: 0.962Mixed Models Analysis
Comparison: Difficulty falling or staying asleepp-value: 0.651Mixed Models Analysis
Comparison: Difficulty rememberingp-value: 0.23Mixed Models Analysis
Comparison: Dizzinessp-value: 0.275Mixed Models Analysis
Comparison: Fatiguep-value: 0.987Mixed Models Analysis
Comparison: Fever, chills, sweatsp-value: 0.037Mixed Models Analysis
Comparison: Nausea or vomitingp-value: 0.534Mixed Models Analysis
Comparison: Neuropathyp-value: 0.002Mixed Models Analysis
Comparison: Skin problemsp-value: 0.349Mixed Models Analysis
Comparison: Weight loss or wastingp-value: 0.02Mixed Models Analysis
Secondary
Change in Quality of Life -- RAND-36
36-Item Short Form Survey (RAND-36) is a widely-used 36-item tool to measure health-related quality of life, where each item in the scale is scored as 0, 25, 50, 75, or 100. Scoring is a two-step process. First, precoded numeric values are recoded per the scoring key so that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores, where a lower score may indicate a better outcome for some of the scales, while it may indicate a better outcome for others.
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Quality of Life -- RAND-36 | Physical Functioning Scale | 66.22 score on a scale | Standard Deviation 31.39 |
| Intervention | Change in Quality of Life -- RAND-36 | Role limitations due to physical health scale | 55.41 score on a scale | Standard Deviation 41.72 |
| Intervention | Change in Quality of Life -- RAND-36 | Role limitations due to emotional problems scale | 62.16 score on a scale | Standard Deviation 43.86 |
| Intervention | Change in Quality of Life -- RAND-36 | Energy/fatigue scale | 51.35 score on a scale | Standard Deviation 18.24 |
| Intervention | Change in Quality of Life -- RAND-36 | Emotional well-being scale | 68.11 score on a scale | Standard Deviation 15.42 |
| Intervention | Change in Quality of Life -- RAND-36 | Social functioning scale | 66.89 score on a scale | Standard Deviation 20.88 |
| Intervention | Change in Quality of Life -- RAND-36 | Pain scale | 69.12 score on a scale | Standard Deviation 20.41 |
| Intervention | Change in Quality of Life -- RAND-36 | General health scale | 60.95 score on a scale | Standard Deviation 21.34 |
| Intervention | Change in Quality of Life -- RAND-36 | Physical health summary scale | 63.18 score on a scale | Standard Deviation 23.8 |
| Intervention | Change in Quality of Life -- RAND-36 | Mental health summary scale | 61.94 score on a scale | Standard Deviation 18.53 |
| Control | Change in Quality of Life -- RAND-36 | General health scale | 60 score on a scale | Standard Deviation 21.28 |
| Control | Change in Quality of Life -- RAND-36 | Physical Functioning Scale | 65.11 score on a scale | Standard Deviation 28.97 |
| Control | Change in Quality of Life -- RAND-36 | Social functioning scale | 65.06 score on a scale | Standard Deviation 26.47 |
| Control | Change in Quality of Life -- RAND-36 | Role limitations due to physical health scale | 61.54 score on a scale | Standard Deviation 41.3 |
| Control | Change in Quality of Life -- RAND-36 | Mental health summary scale | 65.83 score on a scale | Standard Deviation 20.7 |
| Control | Change in Quality of Life -- RAND-36 | Role limitations due to emotional problems scale | 66.66 score on a scale | Standard Deviation 41.43 |
| Control | Change in Quality of Life -- RAND-36 | Pain scale | 63.14 score on a scale | Standard Deviation 27.98 |
| Control | Change in Quality of Life -- RAND-36 | Energy/fatigue scale | 56.54 score on a scale | Standard Deviation 19.67 |
| Control | Change in Quality of Life -- RAND-36 | Physical health summary scale | 63.03 score on a scale | Standard Deviation 21.78 |
| Control | Change in Quality of Life -- RAND-36 | Emotional well-being scale | 73.23 score on a scale | Standard Deviation 19.03 |
Comparison: Physical functioning scalep-value: 0.001Mixed Models Analysis
Comparison: Role limitations due to physical health scalep-value: 0.458Mixed Models Analysis
Comparison: Role limitations due to emotional problems scalep-value: 0.725Mixed Models Analysis
Comparison: Energy/fatigue scalep-value: 0.807Mixed Models Analysis
Comparison: Emotional well-being scalep-value: 0.693Mixed Models Analysis
Comparison: Social functioning scalep-value: 0.128Mixed Models Analysis
Comparison: Pain scalep-value: 0.007Mixed Models Analysis
Comparison: General health scalep-value: 0.96Mixed Models Analysis
Comparison: Physical health summary scalep-value: 0.836Mixed Models Analysis
Comparison: Mental health summary scalep-value: 0.822Mixed Models Analysis
Secondary
Engagement With Healthcare Provider
Engagement with Health Care Provide scale is a 13-item scale in which subjects rate their interactions with their health care providers on a four-point scale with 1=always true and 4=never true in which a lower score indicates a better outcome. The scores are then collated to an aggregate score where the minimum value = 13 and the maximum value = 52. A low score indicates greater provider engagement, where as higher scores indicate lower provider engagement (less favorable outcome). The difference in scores at baseline and follow-up at three months was calculated within both the intervention and control groups, and the difference was then taken between the resulting means of those scores.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Engagement With Healthcare Provider | 16.65 score on a scale | Standard Deviation 6.09 |
| Control | Engagement With Healthcare Provider | 17.59 score on a scale | Standard Deviation 7.56 |
p-value: 0.252Mixed Models Analysis
Secondary
Health-IT Usability Evaluation Scale (Health-ITUES)
Health Information Technology Usability Evaluation Scale (Health-ITUES) was used to measure usability. Health-ITUES consists of 20 items rated on a 5-point Likert scale from strongly disagree (score of 1) to strongly agree (score of 5) measuring actual usage, intention to use, satisfaction, perceived usefulness, perceived ease of use, perceived performance speed, learnability, competency, flexibility/customizability, memorability, error prevention, information needs, and other outcomes. A higher score (5) indicates higher usability. Overall score was calculated as the mean score from the score for quality of life, perceived usefulness, perceived ease of use, and user control.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Health-IT Usability Evaluation Scale (Health-ITUES) | Quality of Life | 4.50 score on a scale | Standard Deviation 0.59 |
| Intervention | Health-IT Usability Evaluation Scale (Health-ITUES) | Perceived ease of use | 4.64 score on a scale | Standard Deviation 0.83 |
| Intervention | Health-IT Usability Evaluation Scale (Health-ITUES) | Perceived usefulness | 4.23 score on a scale | Standard Deviation 0.91 |
| Intervention | Health-IT Usability Evaluation Scale (Health-ITUES) | User control | 4.32 score on a scale | Standard Deviation 0.82 |
| Intervention | Health-IT Usability Evaluation Scale (Health-ITUES) | Overall | 4.39 score on a scale | Standard Deviation 0.72 |
| Control | Health-IT Usability Evaluation Scale (Health-ITUES) | User control | 4.05 score on a scale | Standard Deviation 0.93 |
| Control | Health-IT Usability Evaluation Scale (Health-ITUES) | Overall | 4.35 score on a scale | Standard Deviation 0.63 |
| Control | Health-IT Usability Evaluation Scale (Health-ITUES) | Quality of Life | 4.35 score on a scale | Standard Deviation 0.78 |
| Control | Health-IT Usability Evaluation Scale (Health-ITUES) | Perceived usefulness | 4.26 score on a scale | Standard Deviation 0.74 |
| Control | Health-IT Usability Evaluation Scale (Health-ITUES) | Perceived ease of use | 4.67 score on a scale | Standard Deviation 0.71 |
Comparison: Overallp-value: 0.743Mixed Models Analysis
Comparison: Quality of lifep-value: 0.166Mixed Models Analysis
Comparison: Perceived usefulnessp-value: 0.899Mixed Models Analysis
Comparison: Perceived ease of usep-value: 0.803Mixed Models Analysis
Comparison: User Controlp-value: 0.48Mixed Models Analysis
Secondary
Medication Adherence
Medication adherence was calculated by two scales: the Center for Adherence Support Evaluation (CASE) Adherence Index and the Visual Analogue Scale (VAS). The CASE Adherence Index consists of the composite scores of three questions evaluating self-reported measures of adherence. The minimum score on this scale is 3 while the maximum score on this scale is 16, with higher scores indicating better outcome. Scores greater than 10 indicate good adherence, while scores less than or equal to 10 indicate poor adherence. The VAS asks subjects to indicate a point on a line that shows their best guess about how much of each drug they have taken from a scale of 0% to 100% in which 0% means they have taken no drug, 50% means they have taken half their drugs, and 100% means they have taken every single dose. Consequently, a higher score (100%) indicates
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Medication Adherence | CASE adherence index | 12.97 score on a scale | Standard Deviation 3.51 |
| Intervention | Medication Adherence | Visual analogue scale | 85.97 score on a scale | Standard Deviation 26.86 |
| Control | Medication Adherence | CASE adherence index | 12.69 score on a scale | Standard Deviation 3 |
| Control | Medication Adherence | Visual analogue scale | 87.03 score on a scale | Standard Deviation 20.56 |
Comparison: CASE adherence indexp-value: 0.017Mixed Models Analysis
Comparison: Visual analogue scalep-value: 0.338Mixed Models Analysis
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
The PROMIS-29 includes seven health related quality of life domains on a 5-point scale from a score of 1 to 5 and the pain domain has two subdomains (interference and intensity) where pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain (10). Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. T-scores can be estimated using the scoring tables listed in the PROMIS manuals. A higher PROMIS T-score implies more of the concept being measured; for instance, a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates a greater severity of depression.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression | 54.12 T-score | Standard Deviation 10.46 |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance | 51.21 T-score | Standard Deviation 9.64 |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety | 55.85 T-score | Standard Deviation 9.19 |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Satisfaction with participation in social roles | 48.86 T-score | Standard Deviation 9.01 |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue | 51.76 T-score | Standard Deviation 9.08 |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain interference | 53.60 T-score | Standard Deviation 7.9 |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical Function | 44.69 T-score | Standard Deviation 9.09 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain interference | 53.25 T-score | Standard Deviation 9.84 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical Function | 45.70 T-score | Standard Deviation 9.18 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety | 55.12 T-score | Standard Deviation 10.56 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression | 50.53 T-score | Standard Deviation 9.63 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue | 50.16 T-score | Standard Deviation 9.89 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance | 52.85 T-score | Standard Deviation 9.26 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Satisfaction with participation in social roles | 49.18 T-score | Standard Deviation 8.72 |
Comparison: Physical Functionp-value: 0.529Mixed Models Analysis
Comparison: Anxietyp-value: 0.312Mixed Models Analysis
Comparison: Depressionp-value: 0.841Mixed Models Analysis
Comparison: Fatiguep-value: 0.848Mixed Models Analysis
Comparison: Sleep Disturbancep-value: 0.208Mixed Models Analysis
Comparison: Satisfaction with participation in social rolesp-value: 0.754Mixed Models Analysis
Comparison: Pain interferencep-value: 0.454Mixed Models Analysis