Empowering Cardiovascular Health in Custodial Grandparents
Part of paid clinical trials in Portland, Oregon.
- Sponsor
- Oregon Health and Science University
- Study ID
- NCT07083895
- Status
- Not Yet Recruiting
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Conditions
- Cardiovascular Disease (CVD) Risk Factors
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Modified RICHH — BEHAVIORALThe RICHH intervention is an educational-behavioral and counseling intervention that promotes caregivers' knowledge, skills and motivation to engage in CVD risk reduction. The intervention is delivered individually to caregivers in their homes using video-conferencing technology on mini-iPads. The program consists of 12 weekly sessions \[30-45 minutes\] that will be held at the caregivers' preferred times. RICHH consists of 6 interactive modules (i.e., self-management for heart health, depressive symptom management, heart healthy eating, physical activity, co-morbid condition management, and adherence to medication and smoking cessation). The modified RICHH intervention utilizes focus group outcomes to employ modifications needed to target custodial grandparents from varied backgrounds (e.g., high ACEs, SDoH groups).
- Standard of Care (SOC) — BEHAVIORALReferral to primary care provider
Study Details
In this study, the investigators will tailor an existing intervention (Rural Caregiver Heart Health Education (RICHH)) protocol and test its feasibility, acceptability, and initial effect with grandparent caregivers.
Key Dates
- Start date
- Sep 1, 2026
- Status verified
- May 2026
- Primary completion
- Feb 29, 2028
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 70 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Modified RICHH InterventionThe investigators will employ a re-designed RICHH intervention and determine its feasibility and acceptability with custodial grandparents.
- Active Comparator: Standard of CareThe usual care control group will receive mini-iPads loaded with Caregiver and CVD risk reduction pamphlets in PDF format along with the associated links from the American Heart Association. Because the investigators may identify CVD risk factors in baseline testing in participants who do not know they have them, it would be unethical not to provide at least usual standard of care for these. Thus, all individuals enrolled in the study and in whom the investigators identify CVD risk factors will receive referral to a primary care provider for management of the CVD risk factors identified.
Primary Outcome Measure
Number of participants who complete the intervention and follow-up [ Time Frame: 4 months after baseline and 6 months after baseline ]
Central Contacts
- MinKyoung Song, PhD, RN503-418-2518
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | MinKyoung Song, PhD, RN (PRINCIPAL_INVESTIGATOR) |
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