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

Supporting Mental Health and Reducing Care Stress in Caregivers of Persons With Cardiovascular Disease: A Hybrid Effectiveness-Implementation Study of Caregiving Support in Cardiac Rehabilitation

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Cardiovascular Diseases; Stress; Anxiety; Caregiver Burden
• Intervention / Treatment: Behavioral: Confident Caregiver Intervention

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie T Bidwell, PhD,RN; Phone Number: 503-756-1996; Email: jtbidwell@health.ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California Davis Health System
      • Contact: Julie T Bidwell, PhD, RN; Phone Number: 503-756-1996; Email: jtbidwell@health.ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Confident Caregiver Intervention; 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; All enrolled caregivers receive the Confident Caregiver intervention. No comparison group is included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Caregiver Depression	Change in caregiver depressive symptoms as measured by the PHQ-8 (Patient Health Questionnaire-8). Range 0-24, higher scores indicate greater depressive symptoms.	From baseline to immediately following completion of the Confident Caregiver intervention
Change in Caregiver Anxiety	Change in caregiver symptoms of anxiety as measured by the GAD-7 (Generalized Anxiety Disorder-7). Range 0-21, higher scores indicate greater anxiety symptoms.	From baseline to immediately following completion of the Confident Caregiver intervention
Change in Caregiver Stress (General)	Change in caregiver stress (general) as measured by the PSS-10 (Perceived Stress Scale-10). Range 0-40, higher scores indicate greater stress.	From baseline to immediately following completion of the Confident Caregiver intervention
Change in Overall Caregiving Stress	Change in overall caregiving stress as measured by the ZBI-12 (Short Form Zarit Burden Interview). Range 0-48, higher scores indicate greater stress.	From baseline to immediately following completion of the Confident Caregiver intervention
Change in Caregiver Stress (Physical)	Change in physical caregiving stress (single item from Schulz & Beach). Range 0-3, higher scores indicate greater stress.	From baseline to immediately following completion of the Confident Caregiver intervention
Change in Caregiver Stress (Emotional)	Change in emotional caregiving stress (single item from Schulz & Beach). Range 0-3, higher scores indicate greater stress.	From baseline to immediately following completion of the Confident Caregiver intervention
Change in Caregiver Stress (Financial)	Change in financial caregiving stress (single item from Schulz & Beach). Range 0-3, higher scores indicate greater stress.	From baseline to immediately following completion of the Confident Caregiver intervention
Overall Improvement in Caregiver Well-Being	Average scores on the PCI-13 (Caregiver Perceived Change Index-13) indicative of improvement in caregiving-related factors. Range 13-65, higher scores indicate greater improvement in caregiver well-being.	At time of completion of the Confident Caregiver Intervention
Change in Caregiver Physical Health Status	Change in overall physical health as measured by the PROMIS Global Health-10, Global Physical Health score. Scores are standardized against the US general population, with a mean of 50 representing the population average. Higher scores indicate better physical health.	From baseline to immediately following completion of the Confident Caregiver intervention
Change in Caregiver Mental Health Status	Change in overall mental health as measured by the PROMIS Global Health-10, Global Mental Health score. Scores are standardized against the US general population, with a mean of 50 representing the population average. Higher scores indicate better mental health.	From baseline to immediately following completion of the Confident Caregiver intervention

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Gordon and Betty Moore Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac Rehabilitation; Caregiver Support; Confident Caregiver
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Stress, Psychological; Behavior; Caregiver Burden; Anxiety Disorders; Cardiovascular Diseases; Depression
• Other Study ID Numbers: 2369399; GBMF9048 (Other Grant/Funding Number: Gordon and Betty Moore Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No