Cardiovascular Disease (CVD) Clinical Trial
— CHANGEOfficial title:
Carolina Heart Alliance Networking for Greater Equity (CHANGE)
Verified date | October 2019 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 386 |
Est. completion date | September 29, 2019 |
Est. primary completion date | September 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Centers for Disease Control and Prevention |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiovascular Disease risk score change | Will use the ASCVD pooled 10-year risk calculation to determine estimated 10 year risk of heart attack stroke or death (range 0-100). Will reassess after the 4 month intervention. | 4 months | |
Secondary | Weight | Compare pre-intervention with post-intervention weight | 4 months | |
Secondary | Systolic blood Pressure (SBP) | Compare pre-intervention SBP with post-intervention | 4 months |
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