Empowering Cardiovascular Health in Custodial Grandparents

NCT07083895 | Not Yet Recruiting

• 1 other identifier: STUDY00028858
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Rural Caregiver Heart Health Education (RICHH); Custodial grandparents; Grandparent caregivers; Cardiovascular disease (CVD) risk factors; Community health workers; Grandchildren

Outcome Measures

Primary Outcomes (5)

• Number of participants who complete the intervention and follow-up

  Feasibility is measured by the count of participants who complete the intervention and follow-up components of the study

  4 months after baseline and 6 months after baseline

• Percentage of participants who indicate acceptability of study intervention

  Acceptability will be assessed in the domains of affective attitude, burden, opportunity costs, perceived effectiveness, and self-efficacy

  4 months after baseline

• Physical activity

  Measured using ActiGraph GT9X Link devices. The ActiGraph algorithms generate accurate and reliable data on total energy expenditure (kcal/day). Participants will wear the devices over 7-day periods at each data collection point. For each participant, the average proportion of time per day in moderate-to-vigorous physical activity (MVPA), out of total time wearing the monitors, will be calculated.

  At baseline, 4 months after baseline, and 6 months after baseline

• Food intake

  Measured using the self-report Viocare Food Frequency Questionnaire. Data from Viocare will be used to generate Healthy Eating Index scores, which range from 0 to 100. Higher scores indicate better dietary quality.

  At baseline, 4 months after baseline, and 6 months after baseline

• Body mass index

  BMI (kg/m2) will be calculated from height and body weight measured

  At baseline, 4 months after baseline, and 6 months after baseline

Secondary Outcomes (6)

• Blood pressure

  At baseline, 4 months after baseline, and 6 months after baseline

• Lipids

  At baseline, 4 months after baseline, and 6 months after baseline

• Hemoglobin A1c (HbA1c)

  At baseline, 4 months after baseline, and 6 months after baseline

• Nicotine exposure

  At baseline, 4 months after baseline, and 6 months after baseline

• Depressive symptoms

  At baseline, 4 months after baseline, and 6 months after baseline

Study Arms (2)

Modified RICHH Intervention

EXPERIMENTAL

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

Behavioral: Modified RICHH

Standard of Care

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care (SOC)

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).

Modified RICHH Intervention

Standard of Care (SOC) BEHAVIORAL

Referral to primary care provider

Also known as: Usual Care

Standard of Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Grandparent (inclusion): * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• MinKyoung Song, PhD, RN

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MinKyoung Song, PhD, RN

CONTACT

503-418-2518; songm@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 24, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)