Community Program for Heart Disease Risk Factors

(CIRCLE Trial)

Overseen By Jessica A Reese, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must not be taking: Lipid-lowering, Diabetes medication

Disqualifiers: Pregnancy, Non-English, Institutionalized, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce the risk of heart disease in young American Indians by lowering high levels of fat (lipids) and sugar (glucose) in the blood. Participants will be divided into two groups: one will receive educational materials for self-management, while the other will receive support from a community health worker for guided management to improve diet, exercise, and access to healthcare. The study seeks American Indians aged 18-39 from rural southwestern Oklahoma with high lipid or glucose levels who are not already involved in similar health programs. The goal is to determine if these community-driven programs can effectively lower heart disease risk factors. As an unphased trial, this study offers participants the chance to contribute to important research that could benefit their community's health.

Will I have to stop taking my current medications?

If you are taking medication to lower lipids or treat diabetes, you cannot participate in this trial.

What prior data suggests that this program is safe for young American Indians?

Research has shown that programs designed to manage heart health are generally safe and easy to follow. These programs aim to improve diet, increase physical activity, and educate about heart disease risks. They also strive to make healthcare more accessible. Studies on heart health have found that these lifestyle changes can significantly reduce the risk of heart disease without causing major side effects. Most participants do not experience serious health issues, indicating the safety of this approach. Gradual lifestyle changes have proven both effective and safe for improving heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Program for Heart Disease Risk Factors because it aims to tackle heart health in a new way by focusing on community-driven care. Unlike standard care options, which often rely on individual self-management and generic educational materials, this approach involves guided management with four key components tailored to reduce healthcare access barriers, improve nutrition, increase physical activity, and educate about cardiovascular disease risk factors. This method stands out because it adapts to the specific needs of the community, potentially leading to more effective and personalized interventions for heart disease prevention.

What evidence suggests that this trial's treatments could be effective for lowering heart disease risk factors?

Research has shown that community health workers can help lower the risk of heart disease. In this trial, participants in the guided management arm will receive advice on eating well, exercising, and accessing healthcare. Studies have found that such guidance can improve blood fat and sugar levels, which is linked to better heart health. By focusing on these areas, this guided approach aims to reduce the risk of heart disease. Evidence suggests that personalized help can significantly manage these risk factors. Meanwhile, participants in the self-managed arm will follow a standard of care based on a referral program for risk factor control and educational pamphlets. ^{1 6 7 8 9}

Who Is on the Research Team?

Jessica A Reese, PhD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for American Indians aged 15-39 who are part of the tribal communities in southwestern Oklahoma involved in the Strong Heart Study. Participants must show a tribal membership card or Certificate of Degree of Indian Blood. Only one person per household can join, with an aim for gender balance.

Inclusion Criteria

I am of American Indian heritage.

I am the only one in my household joining this trial.

I am a 15-39 year old American Indian and a member of a participating tribe in southwestern Oklahoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial measurements of lipid and glucose levels, along with other health metrics such as blood pressure, height, weight, diet, and physical activity

1-2 weeks

Intervention

Participants are randomly assigned to either a guided intervention group with community health worker support or a self-managed control group. The intervention includes education on nutrition, physical activity, and CVD risk factors.

18 months

At least 6 quarterly in-person meetings

Follow-up

Participants are monitored for changes in lipid and glucose levels at 9 and 18 months to assess the effectiveness of the intervention

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Guided management
• Self management

Trial Overview The study tests two approaches to improve heart health: one group receives educational booklets on preventing heart disease, while another gets personalized support from community health workers to manage diet, exercise, and healthcare visits.

How Is the Trial Designed?

Group I: Guided management Experimental Treatment 1 Intervention

The intervention will be comprised of four broad components (described below). The focus groups will inform these components and therefore, we propose a community-responsive and ultimately, community-driven intervention. 1. Component on reducing barriers to health care access 2. Nutritional component 3. Activity component 4. CVD risk factor education component

Group II: Self-managed Active Control 2 Interventions

Self-managed (control group): For participants randomized to the self-managed group, we will employ the standard of care that is currently used by the Strong Heart Study (SHS) and other large cohorts, which is based on a referral program for risk factor control and dissemination of educational pamphlets. Therefore, the risk factor control and education for this group will be self-managed.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A study involving 2,127 patients with cardiovascular risk showed that educational group interventions led by nurses saved time, with an average of 39.59 minutes of nurse dedication per patient in the intervention group compared to 60 minutes in the control group.

Despite the time savings, the intervention group experienced an increase in the number of visits and pharmaceutical expenditure, indicating that while group education may be efficient, it did not reduce overall healthcare resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of an educational group intervention in the control of patients with cardiovascular risk]. Puig-Girbau, MN., Lladó-Blanch, MM., Seco-Salcedo, MC., et al.[2011]

In a study involving 161 patients with cardiovascular disease, the Leap for Life program showed that 19% of participants were readmitted to the hospital for cardiovascular issues within 12 months, indicating a need for ongoing support in managing their health.

Participants reported varying levels of goal achievement, with 21% meeting all their health goals and 75% expressing satisfaction with the educational sessions, suggesting that the program effectively addressed their informational needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leap for Life: innovative patient education to optimize outcomes among patients with cardiovascular disease. Castillo, AB., Currie, K., Adams, JL., et al.[2020]

A disease management program for cardiovascular disease (CVD) risk reduction, involving 148 patients with limited healthcare access, led to significant decreases in systolic blood pressure and low-density lipoprotein cholesterol compared to usual care.

The program, which included lifestyle changes and medication, successfully helped more patients move from high-risk to lower-risk categories for CVD, demonstrating its effectiveness in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifactor cardiovascular disease risk reduction in medically underserved, high-risk patients. Haskell, WL., Berra, K., Arias, E., et al.[2006]

In a study involving 428 Veterans with poorly controlled hypertension and/or hypercholesterolemia, a telehealth intervention led by clinical pharmacist specialists did not significantly reduce the Framingham cardiovascular disease (CVD) risk score compared to an education control group over 12 months.

However, the intervention group showed a significant decrease in total cholesterol levels at 6 months, suggesting potential benefits for those who actively engaged with the program, as only 34% of participants completed the recommended intervention calls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine cardiovascular risk reduction in veterans: The CITIES trial. Bosworth, HB., Olsen, MK., McCant, F., et al.[2020]

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