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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

278 participants

Primary outcome timeframe

Baseline, 3, 6, and 9 months' follow-up

Results posted on

2026-08-11

Participant Flow

Participant milestones

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

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-up

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.

Outcome measures

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-up

Depression 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

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-up

Developed 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

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-up

The 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

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-up

Originally 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

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-up

This 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

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-up

In 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

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)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Compass for Care (Safety Intervention)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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.

Phone: 401-360-2985

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place