Recruiting

Confident Caregiver

Sponsor:

UCLA

Code:

NCT07717723

Conditions

Caregiver Burden

Stress

Depression

Anxiety

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Confident Caregiver Intervention

Study Details

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

Study ID

NCT07717723

Start date

Jul 23, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Confident Caregiver Intervention

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

Primary outcome measure

  • 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: From baseline to immediately following completion of the Confident Caregiver intervention ]

Central Contacts and Locations

Central contacts

Julie T Bidwell, PhD,RN

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

Locations

University of California Davis Health System

Recruiting

Sacramento, California, United States, 95817

Contacts

Julie T Bidwell, PhD, RN

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

More Information

Sponsor

University of California, Davis

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • Cardiac Rehabilitation
  • Caregiver Support
  • Confident Caregiver

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-07-27.