Trial Outcomes & Findings for Compass for Care: A Theory-driven Mobile Solution to Promote Well-being Among Caregivers of Individuals With ADRD (NCT NCT06249139)
NCT ID: NCT06249139
Last Updated: 2026-08-11
Results Overview
Developed from the 29 and 22-item versions, the shortened 12-item Zarit Burden Interview measure assesses subjective burden among caregivers of individuals with dementia. Caregivers were asked to rate items (e.g., Do you feel… that your health has suffered because of your involvement with your relative?) on a 5-point scale (0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always. Scores are summed to produce a total score (range 0 to 48), with higher scores indicating a higher level of burden and a worse outcome. Cronbach's alpha is .88.
COMPLETED
NA
278 participants
Baseline, 3, 6, and 9 months' follow-up
2026-08-11
Participant Flow
Participant milestones
| Measure |
Compass for Care (Well-being Intervention)
Participants receive 12 weekly modules containing interactive activities and static content and tailored messages delivered via text message or email. The intervention focuses on five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.
|
Compass for Care (Safety Intervention)
Participants receive 12 weekly modules and tailored messages delivered via text message or email. The intervention focuses on safety behaviors (e.g., weather safety, first aid, home safety, etc.)
|
|---|---|---|
|
Overall Study
STARTED
|
137
|
141
|
|
Overall Study
COMPLETED
|
126
|
111
|
|
Overall Study
NOT COMPLETED
|
11
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Compass for Care: A Theory-driven Mobile Solution to Promote Well-being Among Caregivers of Individuals With ADRD
Baseline characteristics by cohort
| Measure |
Compass for Care (Well-being Intervention)
n=137 Participants
Participants receive 12 weekly modules containing interactive activities and static content and tailored messages delivered via text message or email. The intervention focuses on five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.
|
Compass for Care (Safety Intervention)
n=141 Participants
Participants receive 12 weekly modules and tailored messages delivered via text message or email. The intervention focuses on safety behaviors (e.g., weather safety, first aid, home safety, etc.)
|
Total
n=278 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 Years
STANDARD_DEVIATION 12.3 • n=54 Participants
|
59 Years
STANDARD_DEVIATION 12.1 • n=54 Participants
|
58.7 Years
STANDARD_DEVIATION 12.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=54 Participants
|
129 Participants
n=54 Participants
|
252 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=54 Participants
|
12 Participants
n=54 Participants
|
26 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=54 Participants
|
2 Participants
n=54 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=54 Participants
|
12 Participants
n=54 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=54 Participants
|
117 Participants
n=54 Participants
|
232 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=54 Participants
|
4 Participants
n=54 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=54 Participants
|
4 Participants
n=54 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=54 Participants
|
11 Participants
n=54 Participants
|
20 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
128 Participants
n=54 Participants
|
130 Participants
n=54 Participants
|
258 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Relationship to Care Recipient
Spouse or partner
|
54 Participants
n=54 Participants
|
66 Participants
n=54 Participants
|
120 Participants
n=27 Participants
|
|
Relationship to Care Recipient
Parent or parent -in-law
|
72 Participants
n=54 Participants
|
63 Participants
n=54 Participants
|
135 Participants
n=27 Participants
|
|
Relationship to Care Recipient
Other relative
|
8 Participants
n=54 Participants
|
9 Participants
n=54 Participants
|
17 Participants
n=27 Participants
|
|
Relationship to Care Recipient
Friend or neighbor
|
3 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
|
Annual Household Income
Less than $50,000 per year
|
41 Participants
n=54 Participants
|
49 Participants
n=54 Participants
|
90 Participants
n=27 Participants
|
|
Annual Household Income
$50,000 per year or more
|
96 Participants
n=54 Participants
|
92 Participants
n=54 Participants
|
188 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 9 months' follow-upDeveloped from the 29 and 22-item versions, the shortened 12-item Zarit Burden Interview measure assesses subjective burden among caregivers of individuals with dementia. Caregivers were asked to rate items (e.g., Do you feel… that your health has suffered because of your involvement with your relative?) on a 5-point scale (0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always. Scores are summed to produce a total score (range 0 to 48), with higher scores indicating a higher level of burden and a worse outcome. Cronbach's alpha is .88.
Outcome measures
| Measure |
Compass for Care (Safety Intervention)
n=111 Participants
Participants receive 12 weekly modules and tailored messages delivered via text message or email. The intervention focuses on safety behaviors (e.g., weather safety, first aid, home safety, etc.)
|
Compass for Care (Well-being Intervention)
n=126 Participants
Participants receive 12 weekly modules containing interactive activities and static content and tailored messages delivered via text message or email. The intervention focuses on five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.
|
|---|---|---|
|
Zarit Burden Interview (ZBI)
Baseline
|
28.58 score on a scale
Interval 27.31 to 29.85
|
29.31 score on a scale
Interval 28.02 to 30.59
|
|
Zarit Burden Interview (ZBI)
3-month
|
27.66 score on a scale
Interval 26.37 to 28.96
|
28.71 score on a scale
Interval 27.36 to 30.05
|
|
Zarit Burden Interview (ZBI)
6-month
|
26.64 score on a scale
Interval 25.33 to 27.95
|
28.78 score on a scale
Interval 27.41 to 30.15
|
|
Zarit Burden Interview (ZBI)
9-month
|
27.21 score on a scale
Interval 25.91 to 28.52
|
28.03 score on a scale
Interval 26.67 to 29.39
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 9 months' follow-upDepression was assessed using the Patient Health Questionnaire (PHQ)-8, which is an 8-item measure that asks the number of days in the past two weeks the respondent had experienced each of the Diagnostic and Statistical Manual (DSM) symptoms of depression. Response options are on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day). Scores are summed to produce a total score (range 0 to 24), with higher scores indicating greater symptoms of depression and a worse outcome. Cronbach's alphas across studies/populations vary (e.g. 0.82, 0.89, 0.92).
Outcome measures
| Measure |
Compass for Care (Safety Intervention)
n=111 Participants
Participants receive 12 weekly modules and tailored messages delivered via text message or email. The intervention focuses on safety behaviors (e.g., weather safety, first aid, home safety, etc.)
|
Compass for Care (Well-being Intervention)
n=126 Participants
Participants receive 12 weekly modules containing interactive activities and static content and tailored messages delivered via text message or email. The intervention focuses on five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-8)
Baseline
|
7.96 score on a scale
Interval 7.16 to 8.75
|
8.99 score on a scale
Interval 8.18 to 9.79
|
|
Patient Health Questionnaire (PHQ-8)
3-month
|
6.96 score on a scale
Interval 6.15 to 7.77
|
7.75 score on a scale
Interval 6.91 to 8.6
|
|
Patient Health Questionnaire (PHQ-8)
6-month
|
6.93 score on a scale
Interval 6.1 to 7.75
|
7.81 score on a scale
Interval 6.94 to 8.67
|
|
Patient Health Questionnaire (PHQ-8)
9-month
|
6.85 score on a scale
Interval 6.03 to 7.66
|
7.67 score on a scale
Interval 6.81 to 8.52
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 9 months' follow-upDeveloped by ProChange, this 3-item measure assesses three key drivers of resilience: mindset, meaning, and social connections. Items are rated on a 5-point scale (1 = never, 2 = rarely, 3 = sometimes, 4 = often, and 5 = almost always). Raw scores were summed and standardized to produce a total scale score (range 0 to 100), with higher scores indicating greater resilience and a better outcome. Cronbach's alpha is .81.
Outcome measures
| Measure |
Compass for Care (Safety Intervention)
n=111 Participants
Participants receive 12 weekly modules and tailored messages delivered via text message or email. The intervention focuses on safety behaviors (e.g., weather safety, first aid, home safety, etc.)
|
Compass for Care (Well-being Intervention)
n=126 Participants
Participants receive 12 weekly modules containing interactive activities and static content and tailored messages delivered via text message or email. The intervention focuses on five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.
|
|---|---|---|
|
Resilience Evaluation Measure (REM-3)
Baseline
|
57.21 score on a scale
Interval 54.08 to 60.34
|
55.35 score on a scale
Interval 52.18 to 58.52
|
|
Resilience Evaluation Measure (REM-3)
3-month
|
60.46 score on a scale
Interval 57.26 to 63.66
|
61.18 score on a scale
Interval 57.86 to 64.51
|
|
Resilience Evaluation Measure (REM-3)
6-month
|
59.10 score on a scale
Interval 55.87 to 62.34
|
56.95 score on a scale
Interval 53.55 to 60.34
|
|
Resilience Evaluation Measure (REM-3)
9-month
|
61.03 score on a scale
Interval 57.81 to 64.26
|
56.78 score on a scale
Interval 53.41 to 60.15
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 9 months' follow-upThe WHO-5 is a widely used measure that assesses well-being. Respondents were asked to rate 5 items (e.g., I have felt calm and relaxed) in relation to how they've felt over the last two weeks. Items are rated on a 5-point scale (0 = at no time, 1 = some of the time, 2 = less than half the time, 3 = more than half the time, and 4 = most of the time). Scores were summed to produce a total score (range 0 to 25), with higher scores indicating greater mental well-being and a better outcome. Reported Cronbach's alphas vary (e.g., range from 0.81 to 0.90).
Outcome measures
| Measure |
Compass for Care (Safety Intervention)
n=111 Participants
Participants receive 12 weekly modules and tailored messages delivered via text message or email. The intervention focuses on safety behaviors (e.g., weather safety, first aid, home safety, etc.)
|
Compass for Care (Well-being Intervention)
n=126 Participants
Participants receive 12 weekly modules containing interactive activities and static content and tailored messages delivered via text message or email. The intervention focuses on five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.
|
|---|---|---|
|
World Health Organization Well-Being Index (WHO-5)
Baseline
|
9.63 score on a scale
Interval 8.76 to 10.5
|
9.58 score on a scale
Interval 8.7 to 10.47
|
|
World Health Organization Well-Being Index (WHO-5)
3-month
|
11.18 score on a scale
Interval 10.28 to 12.07
|
11.17 score on a scale
Interval 10.24 to 12.1
|
|
World Health Organization Well-Being Index (WHO-5)
6-month
|
10.53 score on a scale
Interval 9.63 to 11.43
|
10.34 score on a scale
Interval 9.39 to 11.29
|
|
World Health Organization Well-Being Index (WHO-5)
9-month
|
10.92 score on a scale
Interval 10.02 to 11.82
|
10.68 score on a scale
Interval 9.73 to 11.62
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 9 months' follow-upOriginally developed in 1983, the Perceived Stress Scale (PSS) includes 10 items (e.g., In the last month, how often have you felt that you were unable to control the important things in your life) focused on varied situations. Respondents rate the items on a 5-point scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, and 4 = very often). Negatively worded items are reversed scored and scores are summed to produce a total score (range 0 to 40), with higher scores indicating greater perceptions of stress and a worse outcome. Cronbach's alpha ≥ 0.75.
Outcome measures
| Measure |
Compass for Care (Safety Intervention)
n=111 Participants
Participants receive 12 weekly modules and tailored messages delivered via text message or email. The intervention focuses on safety behaviors (e.g., weather safety, first aid, home safety, etc.)
|
Compass for Care (Well-being Intervention)
n=126 Participants
Participants receive 12 weekly modules containing interactive activities and static content and tailored messages delivered via text message or email. The intervention focuses on five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.
|
|---|---|---|
|
Cohen's Perceived Stress
Baseline
|
20.84 score on a scale
Interval 19.93 to 21.76
|
19.56 score on a scale
Interval 18.61 to 20.51
|
|
Cohen's Perceived Stress
3-month
|
20.81 score on a scale
Interval 19.88 to 21.74
|
20.10 score on a scale
Interval 19.1 to 21.1
|
|
Cohen's Perceived Stress
6-month
|
19.70 score on a scale
Interval 18.76 to 20.64
|
19.63 score on a scale
Interval 18.69 to 20.58
|
|
Cohen's Perceived Stress
9-month
|
20.19 score on a scale
Interval 19.21 to 21.17
|
20.45 score on a scale
Interval 19.46 to 21.44
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 9 months' follow-upThis measure of well-being assesses factors associated with increased risk for adverse emotional and physical outcomes among caregivers. Caregivers are asked to rate 13 items (e.g., ability to manage day to day caregiving) on a 5-point scale (1 = gotten much worse, 2 = gotten somewhat worse, 3 = stayed the same, 4 = improved somewhat, and 5 = improved a lot over the past month). The total score was computed by calculating the average of all items (range 0 to 25), with higher scores indicating greater appraisal of self-improvement in well-being and a better outcome. Cronbach's alpha is .88.
Outcome measures
| Measure |
Compass for Care (Safety Intervention)
n=111 Participants
Participants receive 12 weekly modules and tailored messages delivered via text message or email. The intervention focuses on safety behaviors (e.g., weather safety, first aid, home safety, etc.)
|
Compass for Care (Well-being Intervention)
n=126 Participants
Participants receive 12 weekly modules containing interactive activities and static content and tailored messages delivered via text message or email. The intervention focuses on five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.
|
|---|---|---|
|
Perceived Change Index
6-month
|
2.80 score on a scale
Interval 2.68 to 2.91
|
2.78 score on a scale
Interval 2.66 to 2.9
|
|
Perceived Change Index
Baseline
|
2.58 score on a scale
Interval 2.47 to 2.68
|
2.54 score on a scale
Interval 2.43 to 2.65
|
|
Perceived Change Index
3-month
|
2.87 score on a scale
Interval 2.76 to 2.98
|
3.03 score on a scale
Interval 2.91 to 3.14
|
|
Perceived Change Index
9-month
|
2.80 score on a scale
Interval 2.69 to 2.92
|
2.86 score on a scale
Interval 2.75 to 2.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3, 6, and 9 months' follow-upIn its World Poll administered in 150 countries, Gallup, Inc. uses the 2-item Cantril Self-Anchoring Scale and a simple scoring algorithm to assess subjective well-being. Respondents are asked to rate their current life-and then to rate their future life, "say about five years from now"-on a ladder where 0 represents the worst possible life and 10 best possible life. Individuals who rate their current life a "7" or higher AND their future life an "8" or higher are classified as "thriving." Individuals who rate both their current and future lives a "4" or lower are classified as "suffering." All others are "struggling." Those who were classified as "suffering" or "struggling" were collapsed into one category-"not thriving". The probability of "thriving" vs. "not thriving" was assessed.
Outcome measures
| Measure |
Compass for Care (Safety Intervention)
n=111 Participants
Participants receive 12 weekly modules and tailored messages delivered via text message or email. The intervention focuses on safety behaviors (e.g., weather safety, first aid, home safety, etc.)
|
Compass for Care (Well-being Intervention)
n=126 Participants
Participants receive 12 weekly modules containing interactive activities and static content and tailored messages delivered via text message or email. The intervention focuses on five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.
|
|---|---|---|
|
Cantril/Gallup Life Evaluation Index
Baseline
|
0.110 probability of thriving
Interval 0.063 to 0.192
|
0.132 probability of thriving
Interval 0.078 to 0.223
|
|
Cantril/Gallup Life Evaluation Index
3-month
|
0.171 probability of thriving
Interval 0.105 to 0.279
|
0.303 probability of thriving
Interval 0.197 to 0.467
|
|
Cantril/Gallup Life Evaluation Index
6-month
|
0.204 probability of thriving
Interval 0.127 to 0.326
|
0.151 probability of thriving
Interval 0.086 to 0.264
|
|
Cantril/Gallup Life Evaluation Index
9-month
|
0.223 probability of thriving
Interval 0.142 to 0.351
|
0.194 probability of thriving
Interval 0.117 to 0.321
|
Adverse Events
Compass for Care (Well-being Intervention)
Compass for Care (Safety Intervention)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kerry Evers, Ph.D. Co-President and CEO
Pro-Change Behavior Systems, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place