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Not yet recruiting NCT07083895

Empowering Cardiovascular Health in Custodial Grandparents

No phase Interventional Cardiovascular Disease (CVD) Risk Factors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Modified RICHH, Standard of Care (SOC).
Who it may be relevant to
Registry conditions: Cardiovascular Disease (CVD) Risk Factors. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Behavioral 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, depressiv
  • Behavioral Standard of Care (SOC)
    Referral to primary care provider

Primary outcome measures

  • Number of participants who complete the intervention and follow-up [Time frame: 4 months after baseline and 6 months after baseline]
  • Percentage of participants who indicate acceptability of study intervention [Time frame: 4 months after baseline]
  • Physical activity [Time frame: At baseline, 4 months after baseline, and 6 months after baseline]
  • Food intake [Time frame: At baseline, 4 months after baseline, and 6 months after baseline]
  • Body mass index [Time frame: At baseline, 4 months after baseline, and 6 months after baseline]
Secondary outcome measures (6)
  • Blood pressure [Time frame: At baseline, 4 months after baseline, and 6 months after baseline]
  • Lipids [Time frame: At baseline, 4 months after baseline, and 6 months after baseline]
  • Hemoglobin A1c (HbA1c) [Time frame: At baseline, 4 months after baseline, and 6 months after baseline]
  • Nicotine exposure [Time frame: At baseline, 4 months after baseline, and 6 months after baseline]
  • Depressive symptoms [Time frame: At baseline, 4 months after baseline, and 6 months after baseline]
  • Waist circumference [Time frame: At baseline, 4 months after baseline, and 6 months after baseline]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Oregon Health & Science University — Portland

Identifiers

NCT: NCT07083895 · STUDY00028858

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗