Supporting Mental Health and Reducing Care Stress in Caregivers of Persons With Cardiovascular Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Confident Caregiver Intervention
BehavioralAll enrolled caregivers receive the Confident Caregiver intervention. No comparison group is included.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Confident Caregiver InterventionExperimental treatment 1 intervention
Trial outcomes
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.
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 intervention2
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 intervention3
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 interventionSecondary outcomes
1
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 intervention2
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 intervention3
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 intervention4
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
Gordon and Betty Moore Foundation
Collaborator
Source ClinicalTrials.gov