跳至主要内容
临床试验/NCT03582696
NCT03582696已完成不适用

Carolina Heart Alliance Networking for Greater Equity (CHANGE)

University of North Carolina, Chapel Hill8 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2016年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
386
试验地点
8
主要终点
Cardiovascular Disease risk score change

研究概览

简要总结

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.

详细描述

Cardiovascular disease (CVD) is the leading cause of mortality and morbidity among North Carolina (NC) and US adults, yet evidence-based CVD prevention interventions are often minimally implemented and poorly integrated across community and clinical settings. To address this gap, we will develop and test a multi-component strategy to help communities effectively implement evidence-based interventions (EBIs) to prevent CVD. We call our strategy the Carolina Heart Alliance Networking for Greater Equity (CHANGE) strategy. The CHANGE strategy will specifically address NC's large underserved, rural population, which is at increased risk for CVD due in part to behavioral risk factors, including physical inactivity, poor diet, and tobacco use.

The CHANGE strategy is designed to improve the dissemination and implementation of CVD EBIs by strengthening clinical-community linkages. Clinics have strengths in identifying individuals at high risk for cardiovascular disease and prescribing medications and behavioral change to mitigate risk. However, clinics only reach those who seek care, and most clinics lack the capacity to deliver behavioral change EBIs. Public health has strengths in implementing behavioral and environmental change EBIs in the communities where people live. Therefore, the core focus of the CHANGE strategy is to create new structures to leverage the complementary strengths of clinics and public health departments, thereby expanding the reach and effectiveness of both clinic- and community-based EBIs. Because of their potential to reach underserved populations, community health workers (CHWs) are at the center of the CHANGE strategy. Working as part of a clinic/public health collaboration, CHWs will deliver a behavioral change EBI (Heart-to-Health). By linking and leveraging clinical and public health prevention activities, new opportunities for individuals and communities to reduce their risk for CVD will be created. CHWs will be equipped with tablet computers that provide decision support for delivering Heart-to-Health and facilitate linkages among clinics, public health, and community services. Linking services within complex systems is challenging, and many good ideas fall short at the level of implementation. Therefore, the study will apply an effectiveness-implementation hybrid design with a primary focus on the effective implementation of the CHANGE strategy and a secondary focus on its effectiveness at reducing CVD risk. With support and input from community stakeholders the investigators will refine the CHANGE strategy (Year 1), test it in one underserved, rural community (Years 2-3) and then replicate it in a second community (Years 4-5).

Guided by key constructs from implementation science53 and the expanded Chronic Disease Model,54 the study's specific aims are as follows:

Aim 1. Refine the CHANGE strategy through community-engaged formative research to:

(a) identify existing CVD-related clinic and community services and barriers to their use, (b) engage stakeholders in designing the CHWs' roles and systems for integrating their work within clinical and public health practice, and (c) assess the tablet's usability for decision-support and data transfer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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-
  • With no diabetes and no CVD. And, with high blood pressure (HBP) and high cholesterol;
  • Group 2: ages 65-
  • With no diabetes and no CVD. And, with HBP or high cholesterol;
  • Group 3: ages 18-
  • 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-
  • 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-
  • With CVD. And, with one or more of the following: HBP, high cholesterol and/or elevated average blood glucose measure.

排除标准

  • 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.

研究组 & 干预措施

No Arms

Other

Participants are not assigned to randomized study arms or groups.

干预措施: CHANGE Study (Behavioral)

结局指标

主要结局

Cardiovascular Disease risk score change

时间窗: 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.

次要结局

  • Weight(4 months)
  • Systolic blood Pressure (SBP)(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

Loading locations...

相似试验