Empowering Cardiovascular Health in Custodial Grandparents

NCT ID: NCT07083895

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-06-30

Brief Summary

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.

Conditions

Cardiovascular Disease (CVD) Risk Factors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Modified RICHH Intervention

The investigators will employ a re-designed RICHH intervention and determine its feasibility and acceptability with custodial grandparents.

Group Type: EXPERIMENTAL

Modified RICHH

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: BEHAVIORAL

Referral to primary care provider

Interventions

Modified RICHH

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).

Intervention Type: BEHAVIORAL

Standard of Care (SOC)

Referral to primary care provider

Intervention Type: BEHAVIORAL

Other Intervention Names

Usual Care

Eligibility Criteria

Inclusion Criteria

• Provides full-time care to at least one grandchild (< 18 years old) for at least 6 months, with no biological parent residing in the household or providing substantial care to the children
• Lives in Oregon
• Has English proficiency sufficient for informed consent and completion of study measures
• Provides signed informed consent

Grandparent (exclusion)

• Plans for transfer of care to other caregivers or setting for the next 12 months
• Has significant physical or emotional impairment, or psychiatric illness that might interfere with engagement in their own self-management or that is likely to result in their needing a caregiver in the next 12 months
• Chronic drug abuse
• Current active cancer (i.e., undergoing active treatment for cancer) other than isolated skin cancer

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

MinKyoung Song

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MinKyoung Song, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Central Contacts

MinKyoung Song, PhD, RN

Role: CONTACT

songm@ohsu.edu

503-418-2518

Facility Contacts

MinKyoung Song, PhD, RN

Role: primary

songm@ohsu.edu

503-418-2518

Role: backup

songm@ohsu.edu

Other Identifiers

STUDY00028858

Identifier Type: -

Identifier Source: org_study_id