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

NCT06249139 | Completed DMC

• 1 other identifier: 1R44AG076345
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia; Mental Health

Keywords

Transtheoretical Model; Stages of change; Alzheimer's Disease; Caregiving; Dementia; Well-being

Outcome Measures

Primary Outcomes (1)

• Zarit Burden Interview (ZBI)

  Developed from the 29 and 22-item versions, this shortened 12-item Zarit Burden Interview measure assesses subjective burden among caregivers of individuals with dementia. Caregivers are 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 with 0 = never to 4 = nearly always. Cronbach's alpha is .88.

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

Secondary Outcomes (6)

• Patient Health Questionaire (PHQ-9)

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

• Resilience Evaluation Measure (REM-3)

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

• World Health Organization Well-Being Index (WHO-5)

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

• Cohen's Perceived Stress

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

• Perceived Change Index

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

Study Arms (2)

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 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.

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.)

Behavioral: Compass for Care (Safety intervention)

Interventions

Compass for Care (Well-being intervention) BEHAVIORAL

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 (Well-being intervention)

Compass for Care (Safety intervention) BEHAVIORAL

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 (Safety intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 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

You may not qualify if:

• \. Indicating suicidal ideation based upon the PHQ-9 suicidality ideation item (i.e., Thoughts that you would be better off dead, or of hurting yourself)

Sponsors & Collaborators

• Pro-Change Behavior Systems: lead

Study Sites (1)

Pro-Change Behavior Systems

Narragansett, Rhode Island, 02882, United States

Location

MeSH Terms

Conditions

Dementia; Psychological Well-Being; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior; Tauopathies; Neurodegenerative Diseases

Study Officials

• Kerry E Evers, PhD

  Pro-Change Behavior Systems

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: November 13, 2023
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

US (1)