Carolina Heart Alliance Networking for Greater Equity

Completed · Not applicable

Conditions studied: Cardiovascular Disease (CVD)

In brief

In North Carolina, and nationally, cardiovascular disease (CVD) is the leading cause of death and disease among adults. North Carolina adults have high rates of CVD behavioral risk factors such as physical inactivity, unhealthy eating habits, smoking, and being overweight and obese. To help reduce these risks, researchers from the University of North Carolina at Chapel Hill Prevention Research Center (UNC PRC) will test the effectiveness and implementation of Carolina Heart Alliance Networking for Greater Equality (CHANGE). CHANGE is a health promotion strategy to link public health and clinical services through community health workers (CHWs). Primary care clinics, public health, and CHWs all have strengths in addressing chronic disease risk factors, but there is a widely recognized gap in the coordination among them. The CHANGE strategy will use CHWs as members of primary care and public health teams to distribute a behavioral change intervention called Heart-to-Health to a total of 480 clinic patients at risk for CVD. Heart-to-Health is an effective lifestyle and medication adherence intervention that includes a computerized decision aid to guide delivery of tailored counseling sessions. The counseling sessions are focused on diet, physical activity, tobacco cessation, and medication adherence and are facilitated by CHWs using tablet computers. The CHWs will use tablet computers to communicate with a medical home team about important patient health information to be acted on in real time. The CHWs also will link participants to public health and other community based resources to support behavior change. The CHANGE strategy will be tested in one underserved, rural community and then replicated in a second community. Researchers from the UNC PRC will examine whether CHANGE is effective at increasing the reach of clinic and public community services to at risk populations and at improving composite coronary heart disease risk.

Key facts

Study ID: NCT03582696
Run by: University of North Carolina, Chapel Hill
People needed: 386
Starts: 2016-09-11
Expected to finish: 2019-09-29
Last updated by the study team: 2019-10-08

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants are adults ages 18-80 years old who are residents of Hertford, Edgecombe or Nash County, North Carolina or receive public health or healthcare services in Hertford, Edgecombe or Nash County, NC. Additionally, subjects enrolled and receiving services from Roanoke Chowan Community Health Center and OIC Family Medicine AND at elevated risk of a cardiac event. Individuals are at elevated risk if they are represented in any of the following five groups of clinic patients:
Group 1: ages 18-80. With no diabetes and no CVD. And, with high blood pressure (HBP) and high cholesterol;
Group 2: ages 65-80. With no diabetes and no CVD. And, with HBP or high cholesterol;
Group 3: ages 18-80. With diabetes and no CVD. And, with one or more of the following risk factors: HBP, high cholesterol and/or elevated average blood glucose measure;
Group 4: 55-64. With CVD. And, with two or more of the following risk factors: HBP, high cholesterol and/or elevated average blood glucose measure;
Group 5: 65-80. With CVD. And, with one or more of the following: HBP, high cholesterol and/or elevated average blood glucose measure.

You may not qualify if…

Individuals who do not speak English will be excluded from the study because our intervention materials and activities will not be translated into any other languages at this time. We will exclude or withdraw women who report that they are pregnant as pregnancy may account for any changes in weight, BMI and blood pressure.

Where it is running

Roanoke Chowan Community Health Center — Ahoskie, North Carolina, United States
OIC Family Medical Center — Rocky Mount, North Carolina, United States
Edgecombe Health Department — Tarboro, North Carolina, United States
Hertford County Public Health Authority — Winton, North Carolina, United States

Full record on ClinicalTrials.gov

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