Anxiety, Cardiovascular Diseases, Caregiver Burden, Depression, Stress
Conditions
Keywords
Cardiac Rehabilitation, Caregiver Support, Confident Caregiver
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.
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
BEHAVIORALConfident Caregiver Intervention
All enrolled caregivers receive the Confident Caregiver intervention. No comparison group is included.
Sponsors
University of California, Davis
Gordon and Betty Moore Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 |
| 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. | 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 |
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Depression | 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. |
| Change in Caregiver Anxiety | 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. |
| Change in Caregiver Stress (General) | 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. |
| Change in Overall Caregiving Stress | 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. |
| Change in Caregiver Stress (Physical) | 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. |
| Change in Caregiver Stress (Emotional) | 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. |
| Change in Caregiver Stress (Financial) | 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. |
| Overall Improvement in Caregiver Well-Being | 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. |
| Change in Caregiver Physical Health Status | 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. |
| Change in Caregiver Mental Health Status | 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. |
Countries
United States
Contacts
CONTACTJulie T Bidwell, PhD,RN
Outcome results
None listed