Integrated, co-developed intervention for detection and management of cardiometabolic risk factors in older Indians (CARDIO-India)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,824
- 试验地点
- 12
- 主要终点
- Difference in mean delta change of SBP between both arms
研究概览
简要总结
The CARDIO-India study is a cluster randomized controlled trial designed to evaluate the effectiveness and cost-effectiveness of a co-created, technology-enabled, community and primary health system-based intervention to improve early detection, treatment, and management of metabolic risk factors for cardiovascular disease (CVD) among older adults (60 years and above) in India. The intervention (CARDIO-India programme) integrates an electronic Clinical Decision Support System (CDSS), electronic health records, assisted telemedicine, and validated point-of-care testing devices with a patient-facing mobile application (or in-person visits/text messaging/IVRS for those without smartphone access) to enhance self-management and continuity of care. The trial will be implemented through Mobile Healthcare Units (MHUs) operated by HelpAge India in five states. MHUs will be randomized (1:1) into intervention and control arms, with control sites providing usual care. The primary outcome is the change in mean systolic blood pressure at 24 months, with secondary outcomes including CVD risk, metabolic control indicators, quality of life, functional status, self-management, and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants will include older adults aged 60 years and above who have been diagnosed with hypertension (systolic blood pressure more than or equal to 140 mmHg or diastolic blood pressure more than or equal to 90 mmHg, with or without antihypertensive treatment) and are accessing healthcare services for hypertension management from the Mobile Healthcare Units (MHUs) operated by HelpAge India.
排除标准
- •Participants who are unable to provide informed consent and those with serious or terminal illnesses that would impede their ability to participate in study procedures or follow-up assessments, will be excluded from the study.
结局指标
主要结局
Difference in mean delta change of SBP between both arms
时间窗: Primary outcome will be measured at baseline, 12-month and 24-month intervals
次要结局
- Mean change in the physical component score as measured by SF-12(Measured at baseline, 12-month and 24-month follow-up periods)
- Mean change in the cardiovascular disease (CVD) risk assessed by the WHO CVD Risk Chart adapted for the Southeast Asia Region(Measured at baseline, 12-month and 24-month follow-up periods)
- Change in proportion of older people achieving hypertension control(Measured at baseline, 12-month and 24-month follow-up periods)
- Change in proportion of older people achieving glycaemic control(Measured at baseline, 12-month and 24-month follow-up periods)
- Change in proportion of older people achieving hyperlipidaemia (total cholesterol less than 190mg/dl) control(Measured at baseline, 12-month and 24-month follow-up periods)
- Change in proportion of older people with overweight/obesity(Measured at baseline, 12-month and 24-month follow-up periods)
- Mean change in self-management (self-efficacy, adherence to treatment recommendations, changes in tobacco use/smoking, physical activity levels, alcohol use)(Measured at baseline, 12-month and 24-month follow-up periods)
- Change in proportion of older people with depression assessed by PHQ-9(Measured at baseline, 12-month and 24-month follow-up periods)
- Mean change in the Quality of Life (QoL) assessed by EuroQol 5 dimensions (EQ-5D) 3-level version(Measured at baseline, 12-month and 24-month follow-up periods)
- Outcomes related to the care processes (Change in proportion of medication use, healthcare access and utilisation, hospitalisations)(Measured at baseline, 12-month and 24-month follow-up periods)
- Mean change in multidimensional indices of function measured by the WHO Disability Assessment Schedule(Measured at baseline, 12-month and 24-month follow-up periods)
- Mean change in the fried Index and activities of daily living(Measured at baseline, 12-month and 24-month follow-up periods)
研究者
Prof Dorairaj Prabhakaran
Centre for Chronic Disease Control