Caregivers
Conditions
Keywords
caregiving, psychological well-being, Alzheimer's disease, positive emotion
Brief summary
The goal of the proposed intervention, called LEAF (Life Enhancing Activities for Family Caregivers) is to reduce burden and increase well-being in Alzheimer's Disease caregivers through the practice of positive emotion skills. We will employ two methods of online delivery of LEAF: a Zoom facilitated version and a self-guided version, and compare them to an emotion-reporting waitlist control condition. If effective, the LEAF program can be disseminated more broadly to caregivers of individuals with Alzheimer's disease.
Detailed description
LEAF 2.0 is a 3-arm, technology-based, randomized controlled trial (N = 500) in which family caregivers of patients with Alzheimer's Disease (AD) are randomly assigned to 1) the LEAF intervention facilitated remotely via Zoom (N = 200), 2) the LEAF intervention self-guided online (N = 200), or 3) an emotion reporting control (N = 100) which will then cross over to the intervention after approximately 7 months, half to the facilitated arm and half to the self-guided arm. Participants will complete a program that teaches them eight positive emotion skills which aim to reduce stress and burden, and increase positive affect. All aspects of the study (recruitment, consent, intervention, and assessments) are conducted online. To be eligible for participation in LEAF 2.0, participants must identify as the primary family caregiver of someone with Alzheimer's disease or Alzheimer's-related dementia, and whose care recipient is not living in a care facility at the time of enrollment. Primary family caregiver is defined as the person who spends the most time caring for the individual with Alzheimer's disease in a non-professional capacity. Participants must also be able to speak and read English, live in the United States, be at least 18 years of age, and have access to a reliable Wi-Fi connection. Respondents are ineligible if they have already participated in a prior version of LEAF.
Interventions
BEHAVIORALLEAF Positive Emotion Intervention
5-week online intervention teaching 8 positive emotions skills for caregivers
OTHEREmotion Reporting Control Condition
Daily reporting of emotions for participants assigned to the control condition.
Sponsors
University of California, San Francisco
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult age 18 and over who identifies as the primary caregiver of a family member with Alzheimer's disease or probable Alzheimer's * Care recipient does NOT reside in care facility * Speaks and reads English * Has access to high speed internet connection at home or a location where they can speak privately with a facilitator
Exclusion criteria
* Care recipient lives in care facility * Does not speak/read English * Does not have access to internet * Care recipient does not have Alzheimer's disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Using Perceived Stress Scale (PSS-4) | Baseline and 8 weeks post-intervention start date | Used to measure how overloaded, unpredictable, and uncontrollable respondents perceive their lives to be. Scores range from 0 to 40, and higher scores indicate a higher stress level. |
| Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a | Baseline and 8 weeks post-intervention start date | Assesses depressive mood by having participants rate items focused on depressive symptoms over the past 7 days, using scale from Never to Always, where higher scores indicate higher levels of depression. 50 indicates the population mean with a standard deviation of 10. |
| Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a | Baseline and 8 weeks post-intervention start date | Assess momentary positive or rewarding affective experiences, such as feelings and mood associated with pleasure, joy, elation, contentment, pride, affection, happiness, engagement, and excitement, over the past 7 days, using a scale of not at all to very much. Higher scores indicate higher levels of positive affect. 50 indicates the population mean with a standard deviation of 10. |
| Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a | Baseline and 8 weeks post-intervention start date | Assesses anxiety by having participants rate items focused on anxiety symptoms over the past 7 days, using scale from Never to Always, where higher scores indicate higher levels of anxiety. 50 indicates the population mean with a standard deviation of 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire. | Baseline and 8 weeks post-intervention start date | 12-item subscale that measures the caregiver's self-evaluations of their caregiving effectiveness, such as how useful they feel in their interactions with the patient and their capability in caring for the patient. Values range from No! (Disagree very strongly) to Yes! (Agree very strongly). Higher scores indicate higher satisfaction with performance as a caregiver. The total score for this subscale ranges from 12 to 48. |
| Caregiver Burden Measured Using the Zarit Burden Interview. | Baseline and 8 weeks post-intervention start date | Assesses perceived burden in caregivers by assessing subjective feelings of the impact of caregiving on emotional and physical health, financial strain, and social functioning. Scale values range from Never (0) to Nearly Always (4) with higher scores reflect greater burden. Score is a summation of the 6 items. |
| Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure | Baseline and 8 weeks post-intervention start date | 12-item Caregiving Mastery subscale of the Caregiving Appraisal Measure. Values range from Disagree a lot to Agree a lot and Never to Nearly Always with higher scores indicating higher feelings of caregiving mastery. The total score can range from 6 to 30. |
| Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale | Baseline and 8 weeks post-intervention start date | 11-item scale that identifies positive consequences of caregiving, such as feeling more useful, feeling appreciated, and strengthening relationships with others. Values range from Disagree a lot to Agree a lot. Higher scores indicate greater identification of the positives of being a caregiver. The total score can range from 11 to 55. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Meaning and Purpose as Part of Psychological Well-Being, Measured Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Meaning and Purpose 8a | Baseline and 8 weeks post-intervention start date | Assesses the degree to which one feels life has purpose and there are good reasons for living, including hopefulness, optimism, goal-directedness, and feelings that one's life is worthy. Scale values range from Strongly disagree to Strongly agree on items 1-3, and Not at all to Very much on items 4-8, with higher values associated with a higher sense of meaning and purpose. 50 indicates the population mean with a standard deviation of 10. |
| Sleep Disturbance as Part of Psychological Well-Being, Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Sleep Disturbance 8b | Baseline and 8 weeks post-intervention start date | Measures self-reported perceptions of sleep quality, depth, and restoration within the past 7 days, including difficulty falling asleep and staying asleep and sleep satisfaction. Values range from Not at all to very much on items 1-4, Never to Always on items 5-7, and Very poor to Very good on item 8. Higher scores indicate higher levels of sleep disturbance. 50 indicates the population mean with a standard deviation of 10. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Facilitated Intervention Intervention arm facilitated by a trained team member, delivering the 8 positive emotion skills over 5 weeks.
LEAF Positive Emotion Intervention: 5-week online intervention teaching 8 positive emotions skills for caregivers | 154 |
| Self-Guided Intervention Intervention arm that is self-guided on an online platform, delivering the 8 positive emotion skills over 5 weeks.
LEAF Positive Emotion Intervention: 5-week online intervention teaching 8 positive emotions skills for caregivers | 157 |
| Emotion Reporting Control Facilitated Crossover Participants in the emotion reporting control facilitated crossover condition will be reporting their emotions daily for the same length as the intervention before crossing over to the facilitated intervention after 6 months..
Emotion Reporting Control Condition: Daily reporting of emotions for participants assigned to the control condition. | 38 |
| Emotion Reporting Control Self-Guided Crossover Participants in the emotion reporting control self-guided crossover condition will be reporting their emotions daily for the same length as the intervention before crossing over to the self-guided intervention after 6 months.
Emotion Reporting Control Condition: Daily reporting of emotions for participants assigned to the control condition. | 37 |
| Total | 386 |
Baseline characteristics
| Characteristic | Total | Facilitated Intervention | Emotion Reporting Control Self-Guided Crossover | Emotion Reporting Control Facilitated Crossover | Self-Guided Intervention |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 176 Participants | 74 Participants | 17 Participants | 18 Participants | 67 Participants |
| Age, Categorical Between 18 and 65 years | 210 Participants | 80 Participants | 20 Participants | 20 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 8 Participants | 1 Participants | 2 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 367 Participants | 146 Participants | 36 Participants | 36 Participants | 149 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Perceived Stress (PSS) | 7.10 units on a scale STANDARD_DEVIATION 3.08 | 7.08 units on a scale STANDARD_DEVIATION 3.13 | 7.73 units on a scale STANDARD_DEVIATION 3.09 | 6.82 units on a scale STANDARD_DEVIATION 2.88 | 7.04 units on a scale STANDARD_DEVIATION 3.1 |
| PROMIS Anxiety | 56.00 units on a scale STANDARD_DEVIATION 8.11 | 55.62 units on a scale STANDARD_DEVIATION 8.65 | 58.78 units on a scale STANDARD_DEVIATION 8.1 | 55.89 units on a scale STANDARD_DEVIATION 7.48 | 55.73 units on a scale STANDARD_DEVIATION 7.66 |
| PROMIS Depression | 54.42 units on a scale STANDARD_DEVIATION 7.56 | 54.85 units on a scale STANDARD_DEVIATION 7.8 | 56.08 units on a scale STANDARD_DEVIATION 7.67 | 54.08 units on a scale STANDARD_DEVIATION 7.48 | 53.70 units on a scale STANDARD_DEVIATION 7.29 |
| PROMIS Positive Affect | 40.63 units on a scale STANDARD_DEVIATION 8.49 | 40.87 units on a scale STANDARD_DEVIATION 8.88 | 39.29 units on a scale STANDARD_DEVIATION 7.83 | 40.51 units on a scale STANDARD_DEVIATION 7.71 | 40.73 units on a scale STANDARD_DEVIATION 8.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 9 Participants | 2 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 5 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 346 Participants | 137 Participants | 34 Participants | 33 Participants | 142 Participants |
| Region of Enrollment United States | 386 participants | 154 participants | 37 participants | 38 participants | 157 participants |
| Sex/Gender, Customized Gender Female | 330 Participants | 132 Participants | 32 Participants | 33 Participants | 133 Participants |
| Sex/Gender, Customized Gender Male | 55 Participants | 22 Participants | 5 Participants | 5 Participants | 23 Participants |
| Sex/Gender, Customized Gender Prefer Not to Answer | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Zarit Burden Score | 12.45 units on a scale STANDARD_DEVIATION 5.3 | 12.56 units on a scale STANDARD_DEVIATION 5.64 | 13.59 units on a scale STANDARD_DEVIATION 5.58 | 12.21 units on a scale STANDARD_DEVIATION 5.04 | 12.12 units on a scale STANDARD_DEVIATION 4.94 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 154 | 0 / 157 | 0 / 75 |
| other Total, other adverse events | 0 / 154 | 0 / 157 | 0 / 75 |
| serious Total, serious adverse events | 0 / 154 | 0 / 157 | 0 / 75 |
Outcome results
Primary
Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a
Assesses anxiety by having participants rate items focused on anxiety symptoms over the past 7 days, using scale from Never to Always, where higher scores indicate higher levels of anxiety. 50 indicates the population mean with a standard deviation of 10.
Time frame: Baseline and 8 weeks post-intervention start date
Population: Not all enrolled participants completed the post assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Facilitated Intervention | Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a | Baseline | 55.62 score on a scale | Standard Error 0.69 |
| Facilitated Intervention | Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a | 8 weeks post-intervention start date | 54.38 score on a scale | Standard Error 0.71 |
| Self-Guided Intervention | Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a | Baseline | 55.73 score on a scale | Standard Error 0.68 |
| Self-Guided Intervention | Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a | 8 weeks post-intervention start date | 54.51 score on a scale | Standard Error 0.74 |
| Emotion Reporting Control | Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a | Baseline | 57.31 score on a scale | Standard Error 0.98 |
| Emotion Reporting Control | Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a | 8 weeks post-intervention start date | 56.35 score on a scale | Standard Error 1.02 |
Primary
Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a
Assesses depressive mood by having participants rate items focused on depressive symptoms over the past 7 days, using scale from Never to Always, where higher scores indicate higher levels of depression. 50 indicates the population mean with a standard deviation of 10.
Time frame: Baseline and 8 weeks post-intervention start date
Population: Not all enrolled participants completed the post assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Facilitated Intervention | Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a | Baseline | 54.85 score on a scale | Standard Error 0.61 |
| Facilitated Intervention | Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a | 8 weeks post-intervention start date | 53.06 score on a scale | Standard Error 0.64 |
| Self-Guided Intervention | Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a | 8 weeks post-intervention start date | 53.67 score on a scale | Standard Error 0.66 |
| Self-Guided Intervention | Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a | Baseline | 53.70 score on a scale | Standard Error 0.61 |
| Emotion Reporting Control | Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a | Baseline | 55.07 score on a scale | Standard Error 0.88 |
| Emotion Reporting Control | Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a | 8 weeks post-intervention start date | 56.74 score on a scale | Standard Error 0.91 |
Primary
Perceived Stress Using Perceived Stress Scale (PSS-4)
Used to measure how overloaded, unpredictable, and uncontrollable respondents perceive their lives to be. Scores range from 0 to 40, and higher scores indicate a higher stress level.
Time frame: Baseline and 8 weeks post-intervention start date
Population: Not all enrolled participants completed the post assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Facilitated Intervention | Perceived Stress Using Perceived Stress Scale (PSS-4) | Baseline | 7.08 score on a scale | Standard Error 0.26 |
| Facilitated Intervention | Perceived Stress Using Perceived Stress Scale (PSS-4) | 8 weeks post-intervention start date | 6.72 score on a scale | Standard Error 0.27 |
| Self-Guided Intervention | Perceived Stress Using Perceived Stress Scale (PSS-4) | Baseline | 7.04 score on a scale | Standard Error 0.25 |
| Self-Guided Intervention | Perceived Stress Using Perceived Stress Scale (PSS-4) | 8 weeks post-intervention start date | 6.53 score on a scale | Standard Error 0.28 |
| Emotion Reporting Control | Perceived Stress Using Perceived Stress Scale (PSS-4) | Baseline | 7.27 score on a scale | Standard Error 0.37 |
| Emotion Reporting Control | Perceived Stress Using Perceived Stress Scale (PSS-4) | 8 weeks post-intervention start date | 7.56 score on a scale | Standard Error 0.39 |
Primary
Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a
Assess momentary positive or rewarding affective experiences, such as feelings and mood associated with pleasure, joy, elation, contentment, pride, affection, happiness, engagement, and excitement, over the past 7 days, using a scale of not at all to very much. Higher scores indicate higher levels of positive affect. 50 indicates the population mean with a standard deviation of 10.
Time frame: Baseline and 8 weeks post-intervention start date
Population: Not all enrolled participants completed the post-assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Facilitated Intervention | Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a | Baseline | 40.87 score on a scale | Standard Error 0.71 |
| Facilitated Intervention | Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a | 8 weeks post-intervention start date | 42.49 score on a scale | Standard Error 0.75 |
| Self-Guided Intervention | Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a | Baseline | 40.73 score on a scale | Standard Error 0.71 |
| Self-Guided Intervention | Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a | 8 weeks post-intervention start date | 41.36 score on a scale | Standard Error 0.77 |
| Emotion Reporting Control | Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a | Baseline | 39.91 score on a scale | Standard Error 1.02 |
| Emotion Reporting Control | Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a | 8 weeks post-intervention start date | 39.62 score on a scale | Standard Error 1.07 |
Secondary
Caregiver Burden Measured Using the Zarit Burden Interview.
Assesses perceived burden in caregivers by assessing subjective feelings of the impact of caregiving on emotional and physical health, financial strain, and social functioning. Scale values range from Never (0) to Nearly Always (4) with higher scores reflect greater burden. Score is a summation of the 6 items.
Time frame: Baseline and 8 weeks post-intervention start date
Population: Not all enrolled participants completed the post assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Facilitated Intervention | Caregiver Burden Measured Using the Zarit Burden Interview. | Baseline | 12.56 score on a scale | Standard Error 0.42 |
| Facilitated Intervention | Caregiver Burden Measured Using the Zarit Burden Interview. | 8 weeks post-intervention start date | 12.13 score on a scale | Standard Error 0.44 |
| Self-Guided Intervention | Caregiver Burden Measured Using the Zarit Burden Interview. | Baseline | 12.12 score on a scale | Standard Error 0.41 |
| Self-Guided Intervention | Caregiver Burden Measured Using the Zarit Burden Interview. | 8 weeks post-intervention start date | 12.27 score on a scale | Standard Error 0.45 |
| Emotion Reporting Control | Caregiver Burden Measured Using the Zarit Burden Interview. | Baseline | 12.89 score on a scale | Standard Error 0.6 |
| Emotion Reporting Control | Caregiver Burden Measured Using the Zarit Burden Interview. | 8 weeks post-intervention start date | 13.09 score on a scale | Standard Error 0.62 |
Secondary
Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure
12-item Caregiving Mastery subscale of the Caregiving Appraisal Measure. Values range from Disagree a lot to Agree a lot and Never to Nearly Always with higher scores indicating higher feelings of caregiving mastery. The total score can range from 6 to 30.
Time frame: Baseline and 8 weeks post-intervention start date
Population: Not all enrolled participants completed the post assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Facilitated Intervention | Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure | 8 weeks post-intervention start date | 23.89 score on a scale | Standard Error 0.34 |
| Facilitated Intervention | Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure | Baseline | 22.74 score on a scale | Standard Error 0.32 |
| Self-Guided Intervention | Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure | 8 weeks post-intervention start date | 23.79 score on a scale | Standard Error 0.35 |
| Self-Guided Intervention | Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure | Baseline | 22.78 score on a scale | Standard Error 0.32 |
| Emotion Reporting Control | Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure | 8 weeks post-intervention start date | 22.68 score on a scale | Standard Error 0.48 |
| Emotion Reporting Control | Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure | Baseline | 21.93 score on a scale | Standard Error 0.46 |
Secondary
Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale
11-item scale that identifies positive consequences of caregiving, such as feeling more useful, feeling appreciated, and strengthening relationships with others. Values range from Disagree a lot to Agree a lot. Higher scores indicate greater identification of the positives of being a caregiver. The total score can range from 11 to 55.
Time frame: Baseline and 8 weeks post-intervention start date
Population: Not all enrolled participants completed the post assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Facilitated Intervention | Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale | Baseline | 35.85 score on a scale | Standard Error 0.78 |
| Facilitated Intervention | Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale | 8 weeks post-intervention start date | 36.72 score on a scale | Standard Error 0.82 |
| Self-Guided Intervention | Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale | Baseline | 36.14 score on a scale | Standard Error 0.77 |
| Self-Guided Intervention | Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale | 8 weeks post-intervention start date | 37.21 score on a scale | Standard Error 0.85 |
| Emotion Reporting Control | Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale | Baseline | 34.59 score on a scale | Standard Error 1.12 |
| Emotion Reporting Control | Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale | 8 weeks post-intervention start date | 33.74 score on a scale | Standard Error 1.16 |
Secondary
Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire.
12-item subscale that measures the caregiver's self-evaluations of their caregiving effectiveness, such as how useful they feel in their interactions with the patient and their capability in caring for the patient. Values range from No! (Disagree very strongly) to Yes! (Agree very strongly). Higher scores indicate higher satisfaction with performance as a caregiver. The total score for this subscale ranges from 12 to 48.
Time frame: Baseline and 8 weeks post-intervention start date
Population: Not all enrolled participants completed the post assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Facilitated Intervention | Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire. | Baseline | 44.04 score on a scale | Standard Error 0.69 |
| Facilitated Intervention | Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire. | 8 weeks post-intervention start date | 45.80 score on a scale | Standard Error 0.74 |
| Self-Guided Intervention | Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire. | Baseline | 44.81 score on a scale | Standard Error 0.69 |
| Self-Guided Intervention | Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire. | 8 weeks post-intervention start date | 45.45 score on a scale | Standard Error 0.75 |
| Emotion Reporting Control | Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire. | Baseline | 41.87 score on a scale | Standard Error 0.99 |
| Emotion Reporting Control | Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire. | 8 weeks post-intervention start date | 41.98 score on a scale | Standard Error 1.03 |
Other Pre-specified
Meaning and Purpose as Part of Psychological Well-Being, Measured Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Meaning and Purpose 8a
Assesses the degree to which one feels life has purpose and there are good reasons for living, including hopefulness, optimism, goal-directedness, and feelings that one's life is worthy. Scale values range from Strongly disagree to Strongly agree on items 1-3, and Not at all to Very much on items 4-8, with higher values associated with a higher sense of meaning and purpose. 50 indicates the population mean with a standard deviation of 10.
Time frame: Baseline and 8 weeks post-intervention start date
Population: Not all enrolled participants completed the post assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Facilitated Intervention | Meaning and Purpose as Part of Psychological Well-Being, Measured Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Meaning and Purpose 8a | Baseline | 47.28 score on a scale | Standard Error 0.86 |
| Facilitated Intervention | Meaning and Purpose as Part of Psychological Well-Being, Measured Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Meaning and Purpose 8a | 8 weeks post-intervention start date | 49.11 score on a scale | Standard Error 0.89 |
| Self-Guided Intervention | Meaning and Purpose as Part of Psychological Well-Being, Measured Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Meaning and Purpose 8a | Baseline | 47.85 score on a scale | Standard Error 0.85 |
| Self-Guided Intervention | Meaning and Purpose as Part of Psychological Well-Being, Measured Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Meaning and Purpose 8a | 8 weeks post-intervention start date | 48.20 score on a scale | Standard Error 0.92 |
| Emotion Reporting Control | Meaning and Purpose as Part of Psychological Well-Being, Measured Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Meaning and Purpose 8a | Baseline | 46.61 score on a scale | Standard Error 1.23 |
| Emotion Reporting Control | Meaning and Purpose as Part of Psychological Well-Being, Measured Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Meaning and Purpose 8a | 8 weeks post-intervention start date | 46.39 score on a scale | Standard Error 1.27 |
Other Pre-specified
Sleep Disturbance as Part of Psychological Well-Being, Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Sleep Disturbance 8b
Measures self-reported perceptions of sleep quality, depth, and restoration within the past 7 days, including difficulty falling asleep and staying asleep and sleep satisfaction. Values range from Not at all to very much on items 1-4, Never to Always on items 5-7, and Very poor to Very good on item 8. Higher scores indicate higher levels of sleep disturbance. 50 indicates the population mean with a standard deviation of 10.
Time frame: Baseline and 8 weeks post-intervention start date
Population: Not all enrolled participants completed the post assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Facilitated Intervention | Sleep Disturbance as Part of Psychological Well-Being, Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Sleep Disturbance 8b | Baseline | 53.72 score on a scale | Standard Error 0.72 |
| Facilitated Intervention | Sleep Disturbance as Part of Psychological Well-Being, Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Sleep Disturbance 8b | 8 weeks post-intervention start date | 51.80 score on a scale | Standard Error 0.75 |
| Self-Guided Intervention | Sleep Disturbance as Part of Psychological Well-Being, Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Sleep Disturbance 8b | Baseline | 54.78 score on a scale | Standard Error 0.71 |
| Self-Guided Intervention | Sleep Disturbance as Part of Psychological Well-Being, Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Sleep Disturbance 8b | 8 weeks post-intervention start date | 53.58 score on a scale | Standard Error 0.78 |
| Emotion Reporting Control | Sleep Disturbance as Part of Psychological Well-Being, Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Sleep Disturbance 8b | Baseline | 54.53 score on a scale | Standard Error 1.03 |
| Emotion Reporting Control | Sleep Disturbance as Part of Psychological Well-Being, Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Sleep Disturbance 8b | 8 weeks post-intervention start date | 55.37 score on a scale | Standard Error 1.08 |