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

NCT07717723 | Recruiting

• 2 other identifiers: 2369399GBMF9048
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Caregiver Burden; Stress; Depression; Anxiety; Cardiovascular Diseases

Keywords

Cardiac Rehabilitation; Caregiver Support; Confident Caregiver

Outcome Measures

Primary Outcomes (3)

• 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.

  Average change in caregiving difficulty rating across the care challenge areas addressed during the intervention

  From baseline to immediately following completion of the Confident Caregiver intervention

• 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.

  Average change in caregiving upset rating across the care challenge areas addressed during the intervention

  From baseline to immediately following completion of the Confident Caregiver intervention

• 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.

  Average change in caregiving confidence rating across the care challenge areas addressed during the intervention

  From baseline to immediately following completion of the Confident Caregiver intervention

Secondary Outcomes (10)

• Change in Caregiver Depression

  From baseline to immediately following completion of the Confident Caregiver intervention

• Change in Caregiver Anxiety

  From baseline to immediately following completion of the Confident Caregiver intervention

• Change in Caregiver Stress (General)

  From baseline to immediately following completion of the Confident Caregiver intervention

• Change in Overall Caregiving Stress

  From baseline to immediately following completion of the Confident Caregiver intervention

• Change in Caregiver Stress (Physical)

  From baseline to immediately following completion of the Confident Caregiver intervention

Study Arms (1)

Confident Caregiver Intervention

EXPERIMENTAL

Participants receive four individual intervention sessions delivered virtually over approximately 8 to 12 weeks. The intervention includes assessment of caregiving challenges, tailored coaching and action planning to address caregiving challenges, stress reduction strategies, caregiver education, and referrals to services and supports.

Behavioral: Confident Caregiver Intervention

Interventions

Confident Caregiver Intervention BEHAVIORAL

All enrolled caregivers receive the Confident Caregiver intervention. No comparison group is included.

Confident Caregiver Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead
• Gordon and Betty Moore Foundation: collaborator

Study Sites (1)

University of California Davis Health System

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden; Depression; Anxiety Disorders; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Julie T Bidwell, PhD,RN

CONTACT

503-756-1996; jtbidwell@health.ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 21, 2026
• Study Start: July 23, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)