Supporting Mental Health and Reducing Care Stress in Caregivers of Persons With Cardiovascular Di… (NCT07717723) | Clinical Trial Compass
RecruitingNot Applicable
Supporting Mental Health and Reducing Care Stress in Caregivers of Persons With Cardiovascular Disease
United States40 participantsStarted 2026-07-23
Plain-language summary
The purpose of this study is to evaluate the preliminary efficacy, feasibility, acceptability, and barriers and facilitators to implementation of the Confident Caregiver intervention among family caregivers of persons with cardiovascular disease participating in cardiac rehabilitation. Caregivers receive four individualized intervention sessions focused on assessment of caregiving challenges, tailored coaching, stress reduction, education, and referrals to supportive resources. Outcomes include reductions in caregiving-related challenges, improvements in mental health, and reductions in stress.
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:
* 18 years of age or older
* Is a caregiver for a patient receiving care in our UC Davis Cardiac Rehabilitation Clinic. A caregiver is defined as someone who provides support to the patient with one or more basic or instrumental activities of daily living.
* Has one or more caregiving-related challenges or issues that they would like support with
* Is able to read and speak in English
Exclusion Criteria:
* Is a paid professional caregiver with no family or fictive kin relationship with the care recipient
* Has a diagnosis of major cognitive impairment or Alzheimer's or related dementias
* Is unable to complete the protocol or participate in the intervention (e.g., unavailable during the intervention period, unable to access or use virtual meeting technology)
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
Level of Caregiving Difficulty Scale - developed by Gitlin et al and previously used in the COPE trial (Care of Persons With Dementia in Their Environments). Range 1-10, higher scores indicate greater caregiving difficulty.
Timeframe: From baseline to immediately following completion of the Confident Caregiver intervention
2
Level of Caregiving Upset Scale - developed by Gitlin et al and previously used in the COPE trial. Range 1-10, higher scores indicate greater caregiving-related upset.
Timeframe: From baseline to immediately following completion of the Confident Caregiver intervention
3
Level of Caregiving Confidence Scale - developed by Gitlin et al and previously used in the COPE trial. Range 1-10, higher scores indicate greater caregiving confidence.
Timeframe: From baseline to immediately following completion of the Confident Caregiver intervention