跳至主要内容
临床试验/CTRI/2017/08/009387
CTRI/2017/08/009387已完成不适用

SMARThealth Extend: Implementation of the SMARThealth program in Indonesia and North India

George Institute for Global Health Australia2 个研究点 分布在 1 个国家目标入组 23,000 人开始时间: 2017年4月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23,000
试验地点
2
主要终点
Indonesia: Difference in the change in the proportion from baseline to end-of-study of high risk individuals prescribed appropriate preventive medications between the intervention and control arms.

研究概览

简要总结

Brief Summary: (short description of the primary purpose ofthe protocol, including a brief statement of the study hypothesis)

Systematic MedicalAppraisal, Referral and Treatment (SMARThealth) program is a novel primary careplatform to support communities and healthcare providers in the prevention andmanagement of common NCDs.

 The overall SMARThealthpackage includes the Smart Tablet with the SMARThealth Application tailoredtowards identification of individuals at high risk for CVD and providenecessary counseling, referral and follow up. It draws on the principles of“task-sharing†whereby many routine clinical procedures are transferred fromdoctors to non-physician healthcare workers (NPHWs) in an effort to increaseaccess to healthcare and reduce costs. This is facilitated by a suite ofinnovative, affordable digital technologies developed to provide evidence-baseddecision support to both providers and consumers

 The main objective if the SMARThealthextend project is to demonstrate the extent to which the SMARThealth programcan be rapidly customized and scaled up in health systems that might differsubstantially (from the Indonesian province of East Java and the northernIndian state of Haryana), both geographically and demographically, from that inwhich the program was developed (West Godavari District of Andhra Pradesh).

 Non-communicable diseases (NCDs)are already the leading cause of the disease burden faced by Indonesia andIndia. This burden extends from urban areas to many rural regions. In the 2010Global Burden of Disease Project, stroke, ischemic heart disease, diabetes andchronic kidney disease (CKD) were ranked number 1, 7, 5, and 11, respectively,as the causes of premature mortality among all age groups in Indonesia. InIndonesia, it is estimated that one in five Indonesian adults aged 41-50 yearsis at high risk of cardiovascular disease (CVD). This proportion increasessharply to 70% for those aged 51-60 years. Furthermore, two-thirds of those atrisk are not receiving appropriate treatment. There are marked geographicaldisparities, with rural residents much less likely to access CVD care. Thesituation is similar for India, where recent data from rural Andhra Pradeshshows that 18% of the population aged over 40 years has diabetes, and almost40% of these cases were previously undiagnosed. Overall, almost 17% of theadult population was found to be at high short-term risk of CVD and the vastmajority of these individuals were not receiving any preventive drug therapywhatsoever.

 The study is to understand theissues in the rapid customization and scale up of SMARThealth platform indifferent geographical populations and health systems. The project would beimplemented in Jhajjhar district, Haryana, India, covering 4 villages with populationcoverage of about 20000 and 4 villages in Indonesia with a population coverageof about 40,000.The data collection would occur in two occasions in eachvillage – at baseline and at the end of the SMARThealth Extend implementationperiod. The intervention would focus on the routine visits by NPHWs to thehouseholds and evaluating those between 40-85 years for symptoms of CVD andwith support of the Clinical Decision Support System (CDSS) counsel, refer andfollow up the high risk individuals. Mixed methods evaluation will be used toassess feasibility, acceptability, scalability and sustainability. The keyoutput will be a comprehensive policy-framed report for each country,describing the program implementation, reliability and evaluation mechanismsfor integration into the health system framework for NCD prevention.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • participants between 40-85 years.

排除标准

  • Respondents where measurements for blood pressure, height and weight not possible i.e. incapacitated respondents.

结局指标

主要结局

Indonesia: Difference in the change in the proportion from baseline to end-of-study of high risk individuals prescribed appropriate preventive medications between the intervention and control arms.

时间窗: By February 2018

India: Difference in the proportion of high risk individuals prescribed appropriate preventive medications between the screening phase (identified by ASHA) and end of the study evaluation (among those identified as high risk by ASHA during screening)

时间窗: By February 2018

次要结局

  • Indonesia: Diff in the change in the proportion from baseline to end-of-study (EOS) of high risk individuals (HRI) achieving SBP less than 140mmHg between the int and cont arms.(Diff in mean reduction in BP levels between the int and cont arms.)

研究者

发起方
George Institute for Global Health Australia
申办方类型
Research institution

研究点 (2)

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