Empowering Cardiovascular Health in Custodial Grandparents

N/ANot Yet RecruitingNCT07083895

Oregon Health and Science University70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Cardiovascular Disease (CVD) Risk Factors

Interventions

Modified RICHHBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: At baseline, 4 months after baseline, and 6 months after baseline

Secondary Outcomes

Blood pressure

Measured by the average of three consecutive resting blood pressure measurements (both systolic and diastolic pressures).

Central Contacts

MinKyoung Song, PhD, RN

CONTACT

503-418-2518 songm@ohsu.edu

Data from ClinicalTrials.gov

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