Caring4Caregivers: A Theory-driven Mobile Solution to Promote Self-care and Well-being Among Caregivers of Individuals With Alzheimer's and Related Dementias
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 278
- Locations
- 1
- Primary Endpoint
- Zarit Burden Interview (ZBI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Able to read and speak English
- •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 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
Exclusion Criteria
- •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)
Arms & Interventions
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 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.
Intervention: Compass for Care (Well-being intervention) (Behavioral)
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.)
Intervention: Compass for Care (Safety intervention) (Behavioral)
Outcomes
Primary Outcomes
Zarit Burden Interview (ZBI)
Time Frame: 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.
Secondary Outcomes
- 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)
- Patient Health Questionnaire (PHQ-8)(Baseline, 3, 6, and 9 months' follow-up)