Supporting Mental Health and Reducing Care Stress in Caregivers of Persons With Cardiovascular Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Confident Caregiver Intervention.
- Who it may be relevant to
- Registry conditions: Caregiver Burden, Stress, Depression, Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
Interventions
- Behavioral Confident Caregiver Intervention
All enrolled caregivers receive the Confident Caregiver intervention. No comparison group is included.
Primary outcome measures
- 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]
Secondary outcome measures (10)
- Change in Caregiver Depression [Time frame: From baseline to immediately following completion of the Confident Caregiver intervention]
- Change in Caregiver Anxiety [Time frame: From baseline to immediately following completion of the Confident Caregiver intervention]
- Change in Caregiver Stress (General) [Time frame: From baseline to immediately following completion of the Confident Caregiver intervention]
- Change in Overall Caregiving Stress [Time frame: From baseline to immediately following completion of the Confident Caregiver intervention]
- Change in Caregiver Stress (Physical) [Time frame: From baseline to immediately following completion of the Confident Caregiver intervention]
- Change in Caregiver Stress (Emotional) [Time frame: From baseline to immediately following completion of the Confident Caregiver intervention]
- Change in Caregiver Stress (Financial) [Time frame: From baseline to immediately following completion of the Confident Caregiver intervention]
- Overall Improvement in Caregiver Well-Being [Time frame: At time of completion of the Confident Caregiver Intervention]
- Change in Caregiver Physical Health Status [Time frame: From baseline to immediately following completion of the Confident Caregiver intervention]
- Change in Caregiver Mental Health Status [Time frame: From baseline to immediately following completion of the Confident Caregiver intervention]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of California Davis Health System — Sacramento
Identifiers
NCT: NCT07717723 · 2369399 · GBMF9048