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NCT07717723NARecruiting

Supporting Mental Health and Reducing Care Stress in Caregivers of Persons With Cardiovascular Disease

University of California, Davis

Start Date

7/23/2026

Completion Date

12/1/2027

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.

Detailed Description

This Type 1 hybrid effectiveness-implementation study evaluates the Confident Caregiver intervention among family caregivers of persons with cardiovascular disease enrolled in cardiac rehabilitation. The intervention consists of four individualized sessions delivered virtually by a trained interventionist over approximately 8 to 12 weeks. Sessions include assessment of caregiving challenges, tailored coaching and action planning to address caregiving challenges, stress reduction strategies, caregiver education, and referrals to services and supports. Primary intervention efficacy endpoints are: improvement in caregiving challenges and improvement in caregiving-related difficulties Secondary intervention efficacy endpoints are: improvement in caregiver mental health (depression, anxiety), improvement in caregiver stress (both general and caregiving-specific), and improvement in caregiver overall well-being Exploratory intervention efficacy endpoints are: improvement in clinic-level cardiac rehab outcomes for cardiac rehab patients (average # of sessions attended, average program completion, program satisfaction, improvement in patient biomarkers, and improvement in person-centered patient outcomes) Investigators will also evaluate the feasibility and acceptability of intervention for caregiver participants and clinicians in cardiac rehab

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

BEHAVIORAL

Confident Caregiver Intervention

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Conditions

Caregiver BurdenStressDepressionAnxietyCardiovascular Diseases

Locations

University of California Davis Health System

Sacramento, California 95817

United States