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Trial record 5 of 131698 for:    Change

Carolina Heart Alliance Networking for Greater Equity (CHANGE)

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ClinicalTrials.gov Identifier: NCT03582696
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Disease (CVD) Behavioral: CHANGE Study Not Applicable

  Show Detailed Description

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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)
Primary Purpose: Prevention
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

Arm Intervention/treatment
No Arms
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Weight [ Time Frame: 4 months ]
    Compare pre-intervention with post-intervention weight

  2. Systolic blood Pressure (SBP) [ Time Frame: 4 months ]
    Compare pre-intervention SBP with post-intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Samuel Cykert, MD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03582696     History of Changes
Other Study ID Numbers: 15-2822
5U48DP005017-04 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cardiovascular Diseases