Carolina Heart Alliance Networking for Greater Equity (CHANGE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03582696|
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : October 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease (CVD)||Behavioral: CHANGE Study||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||386 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The participants who are engaged with CHWs will be assessed in terms of weight and blood pressure compared to pre-intervention levels and will also complete pre and post dietary and physical activity questionnaires.|
|Masking:||None (Open Label)|
|Official Title:||Carolina Heart Alliance Networking for Greater Equity (CHANGE)|
|Actual Study Start Date :||September 11, 2016|
|Actual Primary Completion Date :||September 29, 2019|
|Actual Study Completion Date :||September 29, 2019|
Participants are not assigned to randomized study arms or groups.
Behavioral: CHANGE Study
The CHANGE strategy is designed to improve the dissemination and implementation of CVD EBIs by strengthening clinical-community linkages
- Cardiovascular Disease risk score change [ Time Frame: 4 months ]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.
- Weight [ Time Frame: 4 months ]Compare pre-intervention with post-intervention weight
- Systolic blood Pressure (SBP) [ Time Frame: 4 months ]Compare pre-intervention SBP with post-intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582696
|United States, North Carolina|
|Roanoke Chowan Community Health Center|
|Ahoskie, North Carolina, United States, 27910|
|OIC Family Medical Center|
|Rocky Mount, North Carolina, United States, 27804|
|Edgecombe Health Department|
|Tarboro, North Carolina, United States, 27886|
|Hertford County Public Health Authority|
|Winton, North Carolina, United States, 27986|
|Principal Investigator:||Samuel Cykert, MD||University of North Carolina, Chapel Hill|