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临床试验/CTRI/2025/04/085098
CTRI/2025/04/085098尚未招募不适用

Strategies for enhanced population engagement and Health Care Seeking for Prevention and Control of Hypertension and Diabetes in India The STEPS INDIA Multi Centre Study

ICMR Headquarters6 个研究点 分布在 1 个国家目标入组 3,900 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
3,900
试验地点
6
主要终点
1.Identification of potential interventions to engage communities for prevention and control of selected Non communicable diseases.Identification of key stakeholders.2.Development of final model 2 of eCES and communication packages required for implementation of interventions 3.For those below 60 years systolic blood pressure more than 140 mmHg and diastolic blood pressure more than 90 mm Hg. For those above 60 years SBP HbA1c below 7 Methods of measurement.

研究概览

简要总结

Hypertension and Diabetes are the most prevalent of all Non-communicable diseases (NCDs). These NCDs are a risk factor for cardiovascular diseases (CVDs), and stroke. Together all NCDs are estimated to account for 63% of all deaths, thus making them the leading causes of death globally and in India. The control of hypertension and diabetes has been shown to reduce premature mortality and prevent or delay the development of complications. However, current control rates of both of these conditions are suboptimal suggesting a need for better and more effective strategies. Meaningful engagement of communities and those living with NCDs has been highlighted in the revised Operational Guidelines of NP-NCD and the WHO Framework on Meaningful Engagement of People Living with NCDs and Mental and Neurological Conditions. Empowering communities to actively manage their health can lead to sustainable, long-lasting solutions for preventing and managing NCDs. It can address not only their health needs but also social, environmental, and behavioural factors. These approaches can lead to a more comprehensive understanding of the factors contributing to NCDs and facilitate more effective solutions. This multi-district research study is aimed at developing and testing strategies for improving community engagement and population healthcare seeking, to improve the cascade of care from screening to control of Hypertension and Diabetes.

The primary objective of the proposed research is to evaluate the effectiveness of enhanced community engagement strategies (eCES) targeted at hypertension and diabetes care within the primary healthcare setting compared to the current standard of care in achieving blood pressure and glycemic control among adults with hypertension and diabetes respectively. The proposed eCES will be co-developed with the communities so that these are context-specific, and socio-culturally appropriate. The current standard of care are existing strategies under the NP-NCD program. As secondary objectives the proposed research aims to evaluate the effectiveness of eCES on population-level screening and diagnosis of hypertension or diabetes; proportions initiated on treatment, adherence to medication and lifestyle advice, and follow-up (continuity of care) among the adults with hypertension or diabetes; reversal among persons with prehypertension (elevated blood pressure) or prediabetes (impaired glycemia), population-level preventive and promotive efforts to reduce the common shared modifiable risk factors for NCDs (namely physical inactivity, unhealthy diet, tobacco use and alcohol use) and level of community participation in the NCD related activities. The study will also evaluate the implementation fidelity of the eCES.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Taking anti-hypertensive or anti-diabetic drugs Detected as having Hypertension OR Diabetes during screening Detected as having elevated blood pressure Detected as having prediabetes OR impaired glycemia.

排除标准

  • Consent refusal for participation Planning to migrate out from the cluster during the study period Individuals confined to bed or with severe chronic conditions (Stroke, Chronic kidney disease).

结局指标

主要结局

1.Identification of potential interventions to engage communities for prevention and control of selected Non communicable diseases.Identification of key stakeholders.2.Development of final model 2 of eCES and communication packages required for implementation of interventions 3.For those below 60 years systolic blood pressure more than 140 mmHg and diastolic blood pressure more than 90 mm Hg. For those above 60 years SBP HbA1c below 7 Methods of measurement.

时间窗: Baseline,12 Months,18 Months

次要结局

  • Reversal of(prehypertension or)

研究者

发起方
ICMR Headquarters
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Roopa Shivashankar

ICMR

研究点 (6)

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