DementiaCompass4CareNCT06249139
Compass for Care: A Theory-driven Mobile Solution to Promote Well-being Among Caregivers of Individuals With ADRD
A study testing Compass for Care (Well-being intervention) and Compass for Care (Safety intervention) in people with Dementia and Mental Health, run by Pro-Change Behavior Systems at 1 site in United States.
Trial summary
In the US, the over 11 million Americans currently providing unpaid care to a family member, relative, or friend with Alzheimer's disease or a related dementia (ADRD) are over 6 times more likely than the general population to suffer from depression (33.9% vs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mental Health
- What is being tested?
- Compass for Care (Well-being intervention) and Compass for Care (Safety intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to 1 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read and speak English
- Aged 18+
- Residing in the U.S.
- Regularly use the internet
- Agree to receive daily messages by email or text during the 3-month intervention period
- Currently providing at least 8 hours of unpaid care to a family member or friend diagnosed with Alzheimer's disease, Lewy body dementia, frontotemporal dementia, vascular dementia, dementia type not specified, or mixed dementia
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- Have been providing care for at least 3 months;
- Score of 3 or higher on the Zarit burden item (Overall, how burdened do you feel in caring for your relative) OR a score of 2 on this item and a score of 2+ on the Patient Health Questionnaire (PHQ)-2 assessment (i.e., Little interest or pleasure in doing things; Feeling down, depressed, or hopeless)
- Expecting to provide care to their family member or friend for at least three more months, or don't know how much longer they will be providing care
Who cannot join
- 1. Indicating suicidal ideation based upon the Patient Health Questionnaire (PHQ)-9 suicidality ideation item (i.e., Thoughts that you would be better off dead, or of hurting yourself)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pro-Change Behavior Systems
Narragansett, Rhode Island, 02882
About this study
Official title: Caring4Caregivers: A Theory-driven Mobile Solution to Promote Self-care and Well-being Among Caregivers of Individuals With Alzheimer's and Related Dementias
In the US, the over 11 million Americans currently providing unpaid care to a family member, relative, or friend with Alzheimer's disease or a related dementia (ADRD) are over 6 times more likely than the general population to suffer from depression (33.9% vs. 5%), and nearly 60% rate their emotional distress as high or very high. The purpose of this Phase II research is to continue the successful work of the pilot development and testing by conducting a rigorous scientific study of the effects of Compass for Care, a digital program that customizes behavior change guidance for using 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.
Read the detailed description
The efficacy of the Compass for Care intervention is being tested in a randomized trial involving up to 305 caregivers caring for a family member or friend with Alzheimer's disease or a related dementia (ADRD). Caregivers who meet study inclusion criteria (e.g., being an ADRD caregiver caring for a family member or friend for 8+ hours/week, residing in the US, agreeing to receive daily text or email messages for three months, not indicating suicidal ideation, and experiencing a level of caregiver burden) as assessed in on online screening survey, are invited to participate in the study.
Caregivers are randomly assigned to either the treatment or attention control condition. The treatment group is provided access to the 12-week Compass for Care mobile first program and attention control group is provided access to a 12-week mobile optimized intervention focused on safety behaviors. Both interventions are delivered in weekly modules and include daily messages delivered by email or text message.
Follow-up assessments are conducted online at 3, 6, and 9 months. Outcomes include caregiver burden, depression, perceived stress, emotional and physical health, life satisfaction, resilience, and well-being. Study protocols include best practices for maximizing retention at follow-up in research.
- Conditions
- Dementia, Mental Health
- Being tested
- Compass for Care (Well-being intervention), Compass for Care (Safety intervention)
- Keywords
- Transtheoretical Model, Stages of change, Alzheimer's Disease, Caregiving, Dementia, Well-being
- Medical subject headings
- Dementia, Psychological Well-Being, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compass for Care (Well-being intervention)Behavioural
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 Alzheimer's disease or a related dementia (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)Behavioural
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.)
| Study group | Role | What they receive |
|---|---|---|
| Compass for Care (Well-being intervention) | Experimental | 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 Alzheimer's disease or a related dementia (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. Receives: Behavioral: Compass for Care (Well-being intervention) |
| Compass for Care (Safety intervention) | Active comparator | 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.) Receives: Behavioral: Compass for Care (Safety intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Burden Interview (ZBI)
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.
Measured: Baseline, 3, 6, and 9 months' follow-up
Secondary outcomes (5)
Patient Health Questionnaire (PHQ-8)
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).
Measured: Baseline, 3, 6, and 9 months' follow-up
Resilience Evaluation Measure (REM-3)
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.
Measured: Baseline, 3, 6, and 9 months' follow-up
World Health Organization Well-Being Index (WHO-5)
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).
Measured: Baseline, 3, 6, and 9 months' follow-up
Cohen's Perceived Stress
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.
Measured: Baseline, 3, 6, and 9 months' follow-up
Perceived Change Index
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.
Measured: Baseline, 3, 6, and 9 months' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start13 Nov 2023
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pro-Change Behavior Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerry E Evers, PhD, Study director, Pro-Change Behavior Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249139
- Sponsor's protocol ID
- 1R44AG076345
- Acronym
- Compass4Care
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2024
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No