Carolina Heart Alliance Networking for Greater Equity

NCT03582696 | Completed

• 2 other identifiers: 15-28225U48DP005017-04
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Cardiovascular Disease (CVD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Weight

  4 months

• Systolic blood Pressure (SBP)

  4 months

Study Arms (1)

No Arms

OTHER

Participants are not assigned to randomized study arms or groups.

Behavioral: CHANGE Study

Interventions

CHANGE Study BEHAVIORAL

The CHANGE strategy is designed to improve the dissemination and implementation of CVD EBIs by strengthening clinical-community linkages

No Arms

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (4)

Roanoke Chowan Community Health Center

Ahoskie, North Carolina, 27910, United States

Location

OIC Family Medical Center

Rocky Mount, North Carolina, 27804, United States

Location

Edgecombe Health Department

Tarboro, North Carolina, 27886, United States

Location

Hertford County Public Health Authority

Winton, North Carolina, 27986, United States

Location

Related Publications (2)

• Samuel-Hodge CD, Ziya Gizlice, Allgood SD, Bunton AJ, Erskine A, Leeman J, Cykert S. A Hybrid Implementation-Effectiveness Study of a Community Health Worker-Delivered Intervention to Reduce Cardiovascular Disease Risk in a Rural, Underserved Non-Hispanic Black Population: The CHANGE Study. Am J Health Promot. 2022 Jul;36(6):948-958. doi: 10.1177/08901171221078272. Epub 2022 Apr 14.

  PMID: 35422132 DERIVED

• Samuel-Hodge CD, Gizlice Z, Allgood SD, Bunton AJ, Erskine A, Leeman J, Cykert S. Strengthening community-clinical linkages to reduce cardiovascular disease risk in rural NC: feasibility phase of the CHANGE study. BMC Public Health. 2020 Feb 21;20(1):264. doi: 10.1186/s12889-020-8223-x.

  PMID: 32085707 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Samuel Cykert, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 11, 2018
• Study Start: September 11, 2016
• Primary Completion: September 29, 2019
• Study Completion: September 29, 2019
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)