Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Reduction in systolic blood pressure
研究概览
简要总结
The purpose of this study is to determine whether a culturally-sensitive multipronged post-discharge intervention can significantly reduce blood pressure, enhance achievement of guideline recommended targets for risk factor control, and lower recurrent vascular events in a low-income and middle-income (LMIC). The study will have 2 Phases - a qualitative phase (Phase 1) lasting less than one year involving development of the intervention through focus group methodologies and structured interviews, and a clinical trial phase (Phase 2)lasting 3 years involving a randomized trial testing the efficacy of the intervention.
详细描述
This research seeks to develop an effective and sustainable way of reducing the devastating and deadly impact of stroke in a low-income region of the world with poor medical infrastructure. It will do so by focusing on improving the treatment of the condition most closely tied to stroke, hypertension, using novel methods that incorporate the input of the local community. If successful, the strategy could serve as a ready model to be adapted by decision-makers in other under-resourced areas for lessening the burden of stroke(and other major public health challenges).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years Stroke within one year access to mobile phone.
排除标准
- •Any medical condition that would limit participation in follow up assessments, Severe cognitive impairment/dementia (MMSE ≤24) Severe global disability (modified Rankin Score ≥ 3).
研究组 & 干预措施
Behavioral
- Pre-appointment phone text
- In-clinic educational video
- Patient report card
- Post-clinic phone text
- Outpatient stroke registry
干预措施: THRIVES (Behavioral)
Standard care
Routine and customary management.
结局指标
主要结局
Reduction in systolic blood pressure
时间窗: 1 year
Reduction in systolic blood pressure at one year post-discharge in stroke patients.
次要结局
- Reduced rate of subsequent primary vascular event(1 year)