Clinical Trials Directory

Trials / Completed

CompletedNCT06249139

Compass for Care: A Theory-driven Mobile Solution to Promote Well-being Among Caregivers of Individuals With ADRD

Caring4Caregivers: A Theory-driven Mobile Solution to Promote Self-care and Well-being Among Caregivers of Individuals With Alzheimer's and Related Dementias

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
305 (actual)
Sponsor
Pro-Change Behavior Systems · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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. 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.

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

Interventions

TypeNameDescription
BEHAVIORALCompass 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.
BEHAVIORALCompass 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.)

Timeline

Start date
2023-11-13
Primary completion
2025-05-27
Completion
2025-05-27
First posted
2024-02-08
Last updated
2025-06-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06249139. Inclusion in this directory is not an endorsement.