Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of… (NCT04247347) | Clinical Trial Compass
CompletedNot Applicable
Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia
United States92 participantsStarted 2019-08-29
Plain-language summary
How do different health self-management interventions (resourcefulness training or biofeedback training) compare to usual care (dementia education) in affecting the health risks, and physical and mental health, of family caregivers of people with dementia? And, how do those health outcomes compare with similar measures for family caregivers of people with bipolar disorder? This one-year supplement study will exam these two aims as part of a larger four-year parent grant (NCT03023332). Caregivers enrolled in the study will be randomized to one of the three self-management interventions, with two data collections time points pre- and post-intervention.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years old
* Have a living family member with Alzheimer's disease or another dementia
* Identify self as a primary caregiver
* In-home caregivers: must be currently providing a minimum of 4 hours per day of supervision/direct care for at least the last 6 months. Caregivers whose family member lives within a facility: must report visiting their care recipient at least once per week for at least the last 6 months.
* Be capable of performing informed consent and participating in study procedures
Exclusion Criteria:
* Does not have family member with Alzheimer's disease or another dementia
* Has not cared for a living family member for at least the last 6 months.
* Has knowledge of another family member in the same household enrolled in the study
* Currently pregnant
* Has a pacemaker
* Lives outside of the study area
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)
Timeframe: From T1 (baseline) through T2 (30 days post-intervention)
2
Change in Health Risk Behavior Scale
Timeframe: From T1 (baseline) through T2 (30 days post-intervention)