Simplified Cardiovascular Management (SimCard) Study – A Cluster-Randomized Trial to Evaluate the Effects of a Simplified Cardiovascular Management Program in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- The primary outcome will be the net differences between the changes in the proportion of high-risk individuals treated with low-dose diuretics pre-and-post intervention between intervention and control villages.
研究概览
简要总结
The overall goal of the present proposal is to develop, pilot test, and evaluate a highly simplified butguideline-based program for cardiovascular management in resource-scarcesettings.The specificaim is to evaluate the effects of implementing a simple low-cost cardiovascular management programfor high-risk individuals, delivered by primary careproviders andcommunity healthcare workers (CHWs), on the proportion of patientsappropriately treated with diuretics as well as a number of secondary outcomes. The main features of the simplified cardiovascular managementprogram include: 1) focus on high-risk for maximal cost-effectiveness; 2)simplified yet evidence-based measures; 3) systematic training of CHWs; 4)healthcare system strengthening with electronic decision support andperformance feedback and payment; 5) adaptive interventional design; and 6)local government support.
Building on our prior experiences, theGeorge Institute for Global Health, China in collaborations with the PublicHealth Foundation of India with cross-fertilizationof ideas and expertise proposes to conduct a cluster-randomized controlled interventional pilot trialin the rural areas in Tibet, Chinaand Haryana, India. In each country, 12villages will be selected to be randomized to receive the intervention (6villages) or usual care (6 villages). Before the intervention begins, avillage-wide screening will be done to identify and measure high-riskindividuals in all villages. The intervention will be one year long. A post-intervention assessment of allhigh-risk individuals will also be conducted. Process evaluation, economicevaluation, and verbal autopsy represent important aspects of the evaluationmatrix. The results of the studyare expected to both advance scientific knowledge to prepare for futurelarge-scale studies and to provide translational evidence necessary for soundpolicy making to address the CVD problem in resource-scarce settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All participants above the age of 40 years will be approached to participate regardless of gender, ethnic group, denomination, or other factors to assess their cardiovascular risk status.From this group subjects having elevated cardiovascular risk will be eligible for enrollment in study. High cardiovascular risk will be defined as: •History of coronary heart disease, ischemic stroke, or hemorrhagic stroke, or •Older age.
- •40 years or older and having diabetes mellitus, or •Older age (40 years or more) and systolic blood pressure more than 160 mmHg on two occasions at least one day apart.
排除标准
- •The research proposes to study adults at high risk for cardiovascular disease, and excludes adults below the age of 40 years.
- •Additional exclusions are: •Subjects with cardiovascular diseases complications whom cannot be managed at primary care settings •Subjects having Malignancy or life-threatening diseases; •Bed-ridden subjects; •Currently participating in a clinical trial;and •Subjects having plans to move in the next 1 year.
结局指标
主要结局
The primary outcome will be the net differences between the changes in the proportion of high-risk individuals treated with low-dose diuretics pre-and-post intervention between intervention and control villages.
时间窗: 12 months
次要结局
- •The net difference in mean post-intervention blood pressure changes of high-risk patients from baseline between intervention and control villages;(•The proportion of high-risk individuals aware of the harms of smoking or high-salt diet;)