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 — BEHAVIORAL
    The 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) — BEHAVIORAL
    Referral 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 Intervention
    The investigators will employ a re-designed RICHH intervention and determine its feasibility and acceptability with custodial grandparents.
  • Active Comparator: Standard of Care
    The 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

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239
MinKyoung Song, PhD, RN
503-418-2518
MinKyoung Song, PhD, RN (PRINCIPAL_INVESTIGATOR)

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