A Randomized, Open Trial Comparing Post Discharge Interventions to Standard Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 806
- 试验地点
- 13
- 主要终点
- To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events
研究概览
简要总结
This is a randomized, open trial comparing post discharge interventions by community health workers (CHW) to standard care in acute coronary syndrome (ACS) patients.
This trial will be conducted in 10 hospitals in India/different parts(both secondary and tertiary care). A total of 800 patients will be recruited, with equal allocation to SPREAD interventions and control groups (usual care)
详细描述
Inclusion criteria:
Consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (CABG surgery or PCI).
Exclusion criteria:
Patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up.
OUTCOME MEASURES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (CABG surgery or PCI).
排除标准
- •Patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up
研究组 & 干预措施
CHW based intervention post ACS
CHW trained and supervised for intervening upon post ACS patients to improve adherence to evidence based care
干预措施: CHW based intervention post ACS (Behavioral)
Standard Care
Patients will be followed upto 12 months without a community health worker intervention as per standard practices of the hospital
结局指标
主要结局
To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events
时间窗: 12 months
Evaluate the rates of adherence to pharmacotherapy and lifestyle modifications using the community health worker
To determine the feasibility of conducting a secondary prevention trial using CDCHWs on adherence to medications and lifestyle advice
时间窗: 12 MONTHS
A pilot study to look at feasibiility of using a trained community health worker to deliver health messages to patients who have had a coronary event
次要结局
未报告次要终点
研究者
Dr Alben Sigamani
Associate Professor
St. John's Research Institute