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

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

American Indians are more likely to die from heart disease compared to other people in the United States. High levels of fat (lipids) and sugar (glucose) in the blood are related to heart disease. Young American Indians who are 18 to 39 years old have high lipid and glucose levels. This has led to heart disease later in life. This means they are likely to benefit from a program to lower these levels. In this project, researchers will work with American Indians in rural southwestern Oklahoma. The researchers will start by asking American Indians how they would like to design a program for younger members of their community. After getting permission, the researchers will take a small amount of blood from young community members. The researchers will measure lipid and glucose levels and ask those with high levels to be in the study. Then the researchers will do several measurements. These will include blood pressure, height, weight, diet, physical activity, sleep, tobacco and alcohol use, access to health care, and social support. The researchers will compare these measurements to similar measurements taken from young American Indians 20 years ago, collected through the Strong Heart Study, which is the longest running study measuring heart disease in American Indians. Next, the researchers want to know if the program they developed with the American Indian communities will work. To do this, they will put people in one of two groups. They will decide which group each person will be in using a process that is like flipping a coin (heads for one group, tails for the other group). One group will receive educational booklets about how to avoid getting heart disease. The other group will receive help from a community health worker. The community health worker will help participants to get to the doctor for treatment. They will also help participants change their diet and exercise routines and provide education about heart disease risk factors. After 9 and 18 months, the researchers will repeat the measurements to see if one of the groups has lower lipid or glucose levels. This program will support the National Heart, Lung, and Blood Institute's mission to "reduce human disease" by lowering lipid and glucose levels, which are related to getting heart disease. This will be done by using the community health worker model to help people go to the doctor and improve their lifestyle related to diet and exercise. The researchers will also be able to advance heart health in American Indians in rural Oklahoma by lowering factors related to heart disease.

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.

Is the Community Program for Heart Disease Risk Factors safe for humans?

The research articles reviewed focus on educational and management interventions for cardiovascular risk, which generally involve safe practices like patient education and self-management. These types of interventions are typically considered safe for human participants. ^{1 2 3 4 5}

How does this treatment for heart disease risk factors differ from other treatments?

This treatment is unique because it focuses on a community-based approach, integrating educational group interventions and self-management programs to empower patients in managing their cardiovascular risk factors. Unlike traditional treatments that may rely solely on medication, this program emphasizes lifestyle changes and patient responsibility, making it particularly beneficial for those with limited access to healthcare. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Guided management, Self management for heart disease risk factors?

Research shows that self-management programs, especially those led by nurses, can improve self-care behaviors and quality of life for heart disease patients. Additionally, educational group interventions and internet-based management programs have been effective in managing cardiovascular risk factors. ^{2 4 10 11 12}

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 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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Patient cardiovascular risk self-management: results from a randomized trial of motivational interviewing delivered by practice nurses. [2020]

2. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of an educational group intervention in the control of patients with cardiovascular risk]. [2011]

3. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of a nurse-led multidisciplinary self-management program for patients with coronary heart disease in communities: A randomized controlled trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A case-management system for coronary risk factor modification after acute myocardial infarction. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Internet based vascular risk factor management for patients with clinically manifest vascular disease: randomised controlled trial. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

Cardiovascular disease risk management for Aboriginal and Torres Strait Islander peoples in primary health care settings: findings from the Kanyini Audit. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Telemedicine cardiovascular risk reduction in veterans: The CITIES trial. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Leap for Life: innovative patient education to optimize outcomes among patients with cardiovascular disease. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a group-based self-management program among congestive heart failure patients. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Multifactor cardiovascular disease risk reduction in medically underserved, high-risk patients. [2006]

11. Israel pubmed.ncbi.nlm.nih.gov

A community program in primary care for control of cardiovascular risk factors: steps in program development. [2004]

12. United States pubmed.ncbi.nlm.nih.gov

A scoping review key elements and effects of cardiovascular disease management programs based on community-based participatory research. [2023]