Caregiver BurdenNCT07717723
Supporting Mental Health and Reducing Care Stress in Caregivers of Persons With Cardiovascular Disease
A study testing Confident Caregiver Intervention in people with Caregiver Burden and Stress, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden, Stress, Depression
- What is being tested?
- Confident Caregiver Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Davis Health System
Sacramento, California, 95817
Julie T Bidwell, PhD, RN, 503-756-1996, jtbidwell@health.ucdavis.edu
About this study
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
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.
Read the 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
- Conditions
- Caregiver Burden, Stress, Depression, Anxiety, Cardiovascular Diseases
- Being tested
- Confident Caregiver Intervention
- Keywords
- Cardiac Rehabilitation, Caregiver Support, Confident Caregiver
- Medical subject headings
- Caregiver Burden, Depression, Anxiety Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confident Caregiver InterventionBehavioural
All enrolled caregivers receive the Confident Caregiver intervention. No comparison group is included.
| Study group | Role | What they receive |
|---|---|---|
| Confident Caregiver Intervention | Experimental | Participants receive four individual intervention sessions delivered virtually over approximately 8 to 12 weeks.
The intervention includes assessment of caregiving challenges, tailored coaching and action planning to address caregiving challenges, stress reduction strategies, caregiver education, and referrals to services and supports. Receives: Behavioral: Confident Caregiver Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: From baseline to immediately following completion of the Confident Caregiver intervention
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to immediately following completion of the Confident Caregiver intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start23 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717723
- Sponsor's protocol ID
- 2369399
- Other IDs
- GBMF9048
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07717723
- Acronym / sponsor ID
- 2369399
- Conditions
- Caregiver Burden, Stress, Depression, Anxiety, Cardiovascular Diseases
- Keywords
- Cardiac Rehabilitation, Caregiver Support, Confident Caregiver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confident Caregiver Intervention | Experimental | Behavioral: Confident Caregiver InterventionParticipants receive four individual intervention sessions delivered virtually over approximately 8 to 12 weeks. The intervention includes assessment of caregiving challenges, tailored coaching and action planning to address caregiving challenges, stress reduction strategies, caregiver education, and referrals to services and supports. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Confident Caregiver InterventionAll enrolled caregivers receive the Confident Caregiver intervention. No comparison group is included. | Behavioural | Confident Caregiver Intervention |
Primary outcome
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
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
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
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confident Caregiver Intervention in people with Caregiver Burden and Stress, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie T Bidwell, PhD,RN (503-756-1996, jtbidwell@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.