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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
All enrolled caregivers receive the Confident Caregiver intervention. No comparison group is included.
University of California Davis Health System
Sacramento, California, United States
RECRUITINGLevel 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
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.
Average change in caregiving upset rating across the care challenge areas addressed during the intervention
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.
Average change in caregiving confidence rating across the care challenge areas addressed during the intervention
Time frame: From baseline to immediately following completion of the Confident Caregiver intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to immediately following completion of the Confident Caregiver intervention
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