Bridging Income Generation with Group Integrated Care (BIGPIC)

 描述（由申请人提供）：通过团体综合护理（BIGPIC）桥接创收心血管疾病（CVD）是世界上死亡的主要原因。糖尿病是心血管疾病的主要危险因素，其发病率和死亡率越来越高。血压升高（BP）会增加糖尿病和前驱糖尿病患者的CVD风险;因此，BP控制是降低CVD风险的有效方法。具有成本效益、针对具体情况和文化上适当的干预措施至关重要，集体医疗访问和小额供资都有可能实现这一目标。提供保健机会学术模式伙伴关系与肯尼亚政府合作，扩大了其在肯尼亚西部农村的临床工作范围，将糖尿病和高血压纳入其中，并试行了集体护理和小额供资举措，取得了可喜的初步成果。然而，这些策略单独和组合对改善CVD风险的有效性尚不清楚。因此，本提案的总体目标是利用跨学科的实施研究方法来应对在低资源环境中降低CVD风险的挑战。具体而言，我们建议测试的假设，即小组医疗访问整合到小额信贷团体将是有效的和具有成本效益的降低心血管疾病风险的糖尿病患者和在肯尼亚西部糖尿病的风险增加。我们进一步假设，社会网络特征的变化可能会介导这些干预措施的影响，而基线社会网络特征可能会缓和这种影响。目的1是确定背景因素，促进者，和障碍，可能会影响整合的团体医疗访问和小额信贷团体在这种情况下，使用新的定性研究技术。然后，我们将设计一个上下文和文化上适当的综合团体医疗访视小额信贷模式，降低心血管疾病的风险。目的2是通过进行一项四臂群集随机试验，比较：1）常规临床护理; 2）仅常规临床护理加小额信贷组; 3）仅团体医疗访视; 4）纳入小额信贷组的团体医疗访视，评估团体医疗访视和小额信贷组在糖尿病患者或糖尿病风险增加的人群中降低心血管疾病风险的有效性。主要结局将是收缩压的一年变化，关键次要结局将是QRISK 2 CVD风险评分的变化。我们亦会进行中介分析和适度分析，以评估社会网络特征对干预结果的影响。目的3是评估试验中每个干预组的增量成本效益。该研究将由一名在低资源环境下具有丰富实施研究经验的早期主要研究者完成，并由一个具有多样化和互补专业知识的跨学科研究团队提供支持。我们的目标是增加现有的创新，可扩展和可持续战略的知识基础，以减少全球低资源环境中糖尿病和其他慢性疾病的CVD风险。

 DESCRIPTION (provided by applicant): Bridging Income Generation with Group Integrated Care (BIGPIC) Cardiovascular disease (CVD) is the leading cause of mortality in the world. Diabetes, a major risk factor for CVD, is increasingly prevalent and responsible for substantial cardiovascular morbidity and mortality. Elevated blood pressure (BP) increases CVD risk among individuals with diabetes and pre-diabetes; BP control is therefore a powerful way to reduce CVD risk. Cost-effective, context-specific, and culturally appropriate interventions are critical, and both group medical visits and microfinance have the potential to achieve this. In partnership with the Government of Kenya, the Academic Model Providing Access to Healthcare Partnership has expanded its clinical scope of work in rural western Kenya to include diabetes and hypertension, and has piloted group care and microfinance initiatives with promising early results. However, the effectiveness of these strategies individually, and in combination, on improving CVD risk is not known. Thus, the overall objective of this proposal is to utilize a transdisciplinary implementation research approach to address the challenge of reducing CVD risk in low-resource settings. Specifically, we propose to test the hypothesis that group medical visits integrated into microfinance groups will be effective and cost-effective in reducing CVD risk among individuals with diabetes and at increased risk for diabetes in western Kenya. We further hypothesize that changes in social network characteristics may mediate the impact of these interventions, and that baseline social network characteristics may moderate the impact. Aim 1 is to identify contextual factors, facilitators, and barriers that may impact integration of group medical visits and microfinance groups in this setting, using novel qualitative research techniques. We will then design a contextually and culturally appropriate integrated group medical visit-microfinance model for CVD risk reduction. Aim 2 is to evaluate the effectiveness of group medical visits and microfinance groups for CVD risk reduction among individuals with diabetes or at increased risk of diabetes, by conducting a four-arm cluster randomized trial comparing: 1) usual clinical care; 2) usual clinical care plus microfinance groups only; 3) group medical visits only; and 4) group medical visits integrated into microfinance groups. The primary outcome will be one-year change in systolic BP, and a key secondary outcome will be change in QRISK2 CVD risk score. We will also conduct mediation analysis and moderation analysis to evaluate the influence of social network characteristics on intervention outcomes. Aim 3 is to evaluate the incremental cost-effectiveness of each intervention arm of the trial. The research will be accomplished by an Early Stage Principal Investigator with extensive experience in implementation research in low-resource settings, supported by a transdisciplinary team of investigators with diverse and complementary expertise. Our goal is to add to the existing knowledge base of innovative, scalable, and sustainable strategies to reduce CVD risk in diabetes and other chronic diseases in low-resource settings worldwide.