Empowering Cardiovascular Health in Custodial Grandparents (ECG)

Oregon Health & Science University (OHSU)

Status: Not yet enrolling

Conditions: Cardiovascular Disease (CVD) Risk Factors

Treatments: Behavioral: Standard of Care (SOC); Behavioral: Modified RICHH

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07083895

STUDY00028858

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Modified RICHH Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Modified RICHH

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of Care (SOC)