Modified RICHH for Cardiovascular Health

(ECG Trial)

Overseen By MinKyoung Song, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Physical impairment, Psychiatric illness, Drug abuse, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a modified version of the Rural Caregiver Heart Health Education program (Modified RICHH) to determine its effectiveness in improving heart health for grandparents who are primary caregivers for their grandchildren. Researchers aim to assess the program's usability and participant satisfaction. Participants will either engage with the new program or continue with the usual care, which includes resources on mini-iPads. This trial suits grandparents in Oregon who have cared for their grandchildren full-time for at least six months without the parents present. As an unphased trial, this study provides an opportunity to contribute to valuable research that could enhance heart health education for caregivers.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Modified RICHH protocol is safe for grandparent caregivers?

Research has shown that healthy lifestyle changes, like eating well and exercising, can improve heart health. These changes reduce risks related to heart disease, such as high blood pressure and high cholesterol. The Modified RICHH treatment focuses on these lifestyle changes, making it likely safe for most people.

Such changes usually don't cause serious side effects because they involve adjusting daily habits rather than taking medications. Participants in similar studies generally found these changes manageable, reporting no major problems or discomfort.

Overall, the emphasis on diet and exercise in the Modified RICHH treatment suggests it is a safe way to improve heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Modified RICHH treatment because it offers a new approach to improving cardiovascular health, especially for custodial grandparents. Unlike standard care, which typically involves medication and lifestyle recommendations, the Modified RICHH intervention is designed to be a more holistic and tailored method that focuses on feasibility and acceptability for this specific population. By re-designing the intervention to meet the unique needs of custodial grandparents, this approach aims to provide a more personalized and potentially more effective solution for managing cardiovascular risk factors.

What evidence suggests that the Modified RICHH intervention is effective for cardiovascular health?

Research has shown that changing certain lifestyle habits can effectively lower the risk of heart disease. This trial tests the modified RICHH program, an intervention designed to improve heart health through proven lifestyle changes. Similar programs have successfully reduced heart disease risks by promoting healthy habits, leading to lasting improvements in heart health. The modified RICHH program tailors these strategies to meet the needs of grandparents who are caregivers, making it a promising option for them. Participants in the trial will receive either the modified RICHH intervention or standard care, which includes educational materials and referrals for managing identified CVD risk factors. ^{6 7 8 9 10}

Who Is on the Research Team?

MinKyoung Song, PhD, RN

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for grandparents in Oregon who have been the primary caregivers of a grandchild under 18 years old for at least 6 months, with no biological parent providing substantial care. Participants must be able to give informed consent and speak English well enough to engage with study materials. They should not plan on transferring caregiving duties, have chronic drug abuse issues, significant impairments or illnesses that could interfere with self-care, or be undergoing active cancer treatment.

Inclusion Criteria

I have signed the consent form.

I plan to change my healthcare provider or setting within the next year.

I do not use drugs chronically.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of participants including measurement of lipids, HbA1c, nicotine exposure, physical activity, food intake, BMI, blood pressure, depressive symptoms, and waist circumference

1 week

1 visit (in-person)

Intervention

Participants receive the modified RICHH intervention or standard of care, including educational materials and referrals for CVD risk management

4 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments at 4 and 6 months post-baseline

2 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Modified RICHH

Trial Overview The study is testing a tailored version of the Rural Caregiver Heart Health Education (RICHH) protocol against the Standard of Care (SOC) to see if it's feasible and acceptable for custodial grandparents and what effect it has on their cardiovascular health.

How Is the Trial Designed?

Group I: Modified RICHH Intervention Experimental Treatment 1 Intervention

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

Group II: Standard of Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07083895

Empowering Cardiovascular Health in Custodial ... The modified RICHH intervention utilizes focus group outcomes to employ modifications needed to target custodial grandparents from varied backgrounds (e.g. ...

2. withpower.com withpower.com/trial/phase-cardiovascular-diseases-9-2025-6cf74

Modified RICHH for Cardiovascular Health (ECG Trial) In this study, the investigators will tailor an existing intervention (Rural Caregiver Heart Health Education (RICHH)) protocol and test its feasibility, ...

3. acc.org acc.org/Latest-in-Cardiology/Articles/2022/11/01/22/00/sun-530pm-htn-combined-aha-2022

CRHCP, RICH LIFE, MB-BP, QUARTET USA Trials Explore ... Researchers found that village doctor-led hypertension intervention was effective in reducing cardiovascular disease and all-cause mortality in rural villages ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10460604/

Impact of Lifestyle Modifications on Cardiovascular Health These modifications have a cumulative effect on cardiovascular health, resulting in sustained improvements and a lower risk of adverse events over time [6]. ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0939475325002844

The effectiveness of lifestyle interventions in reducing ... This systematic review and meta-analysis examined the effectiveness of lifestyle interventions in reducing cardiovascular disease (CVD) risk, CVD events, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5958918/

Socioeconomic Status and Cardiovascular Outcomes Socioeconomic status (SES) has a measurable and significant effect on cardiovascular health. Biologic, behavioral, and psychosocial risk factors prevalent ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.121.319811

Social Determinants of Cardiovascular Disease Mixed methods approaches combining qualitative and quantitative data are also critical in cardiovascular intervention development that ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S003306202100133X

The importance of healthy lifestyle behaviors in ... HL behaviors, such as regular exercise, healthy eating habits, adequate sleep, and smoking cessation, can influence a number of traditional CVD risk factors.

9. cureus.com cureus.com/articles/172900-impact-of-lifestyle-modifications-on-cardiovascular-health-a-narrative-review

Impact of Lifestyle Modifications on Cardiovascular Health A heart-healthy diet promotes the control of blood pressure, another significant risk factor for CVDs. A diet rich in fruits, vegetables, whole ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6100800/

Cardiovascular Disease Prevention by Diet Modification Reduction in excess calories and improvement in dietary composition may prevent many primary and secondary cardiovascular events.