Clinical trial NCT06249139: Compass for Care: A Theory-driven Mobile Solution to Promote Well-being Among Caregivers of Individuals With ADRD
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Mental Health
Keywords: Transtheoretical Model
Stages of change
Alzheimer's Disease
Caregiving
Dementia
Well-being
Lead sponsor: Pro-Change Behavior Systems
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Able to read and speak English
2. Aged 18+
3. Residing in the U.S.
4. Regularly use the internet
5. Agree to receive daily messages by email or text during the 3-month intervention period
6. 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
7. Have been providing care for at least 3 months;
8. 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)
9. 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

Exclusion Criteria:

1. 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)

Primary outcomes:
measure: Zarit Burden Interview (ZBI)
timeFrame: Baseline, 3, 6, and 9 months' follow-up
Secondary outcomes:
measure: Patient Health Questionaire (PHQ-9)
timeFrame: Baseline, 3, 6, and 9 months' follow-up
measure: Resilience Evaluation Measure (REM-3)
timeFrame: Baseline, 3, 6, and 9 months' follow-up
measure: World Health Organization Well-Being Index (WHO-5)
timeFrame: Baseline, 3, 6, and 9 months' follow-up
measure: Cohen's Perceived Stress
timeFrame: Baseline, 3, 6, and 9 months' follow-up
measure: Perceived Change Index
timeFrame: Baseline, 3, 6, and 9 months' follow-up
measure: Cantril/Gallup Life Evaluation Index
timeFrame: Baseline, 3, 6, and 9 months' follow-up
Other outcomes:
Locations:
city: Narragansett
country: United States
facility: Pro-Change Behavior Systems
state: Rhode Island
Study officials:
affiliation: Pro-Change Behavior Systems
name: Kerry E Evers, PhD
role: STUDY_DIRECTOR
References: