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NCT Number: NCT07717723

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

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.

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Key information

Conditions

Caregiver Burden Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cardiovascular Diseases Depression Mental Disorders Stress Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis Health System

Sacramento, California, 95817, United States

Location status: Recruiting

Location contact

Julie T Bidwell, PhD, RN

CONTACT

[email protected]

503-756-1996

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Confident Caregiver Intervention

Behavioral

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

Primary outcomes

  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.

    Time frame: From baseline to immediately following completion of the Confident Caregiver intervention

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

    Time frame: From baseline to immediately following completion of the Confident Caregiver intervention

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

    Time frame: From baseline to immediately following completion of the Confident Caregiver intervention

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

Secondary outcomes

  1. Change in Caregiver Depression

    Time frame: From baseline to immediately following completion of the Confident Caregiver intervention

    Change in caregiver depressive symptoms as measured by the PHQ-8 (Patient Health Questionnaire-8). Range 0-24, higher scores indicate greater depressive symptoms.

  2. Change in Caregiver Anxiety

    Time frame: From baseline to immediately following completion of the Confident Caregiver intervention

    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.

  3. Change in Caregiver Stress (General)

    Time frame: From baseline to immediately following completion of the Confident Caregiver intervention

    Change in caregiver stress (general) as measured by the PSS-10 (Perceived Stress Scale-10). Range 0-40, higher scores indicate greater stress.

  4. Change in Overall Caregiving Stress

    Time frame: From baseline to immediately following completion of the Confident Caregiver intervention

    Change in overall caregiving stress as measured by the ZBI-12 (Short Form Zarit Burden Interview). Range 0-48, higher scores indicate greater stress.

  5. Change in Caregiver Stress (Physical)

    Time frame: From baseline to immediately following completion of the Confident Caregiver intervention

    Change in physical caregiving stress (single item from Schulz & Beach). Range 0-3, higher scores indicate greater stress.

  6. Change in Caregiver Stress (Emotional)

    Time frame: From baseline to immediately following completion of the Confident Caregiver intervention

    Change in emotional caregiving stress (single item from Schulz & Beach). Range 0-3, higher scores indicate greater stress.

  7. Change in Caregiver Stress (Financial)

    Time frame: From baseline to immediately following completion of the Confident Caregiver intervention

    Change in financial caregiving stress (single item from Schulz & Beach). Range 0-3, higher scores indicate greater stress.

  8. Overall Improvement in Caregiver Well-Being

    Time frame: At time of completion of the Confident Caregiver Intervention

    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.

  9. Change in Caregiver Physical Health Status

    Time frame: From baseline to immediately following completion of the Confident Caregiver intervention

    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.

  10. Change in Caregiver Mental Health Status

    Time frame: From baseline to immediately following completion of the Confident Caregiver intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie T Bidwell, PhD,RN

CONTACT

[email protected]

503-756-1996

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Gordon and Betty Moore Foundation

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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