A multicentric prospective trial on smartphone-based medication adherence and risk factor control for secondary prevention of stroke and decentralizing stroke care in Kerala.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Primary outcome:
研究概览
简要总结
This study aims to validate the use of a smartphone-based app for medication adherence, vascular risk factor control, lifestyle and behavioral modification among stroke survivors in Kerala and also to evaluate the usability of this smartphone-based app by the participants for secondary prevention of stroke. The study will also assess the barriers and facilitators for medication adherence and vascular risk factor monitoring for secondary prevention of stroke among stroke survivors,determine the utilization of primary health centres (PHCs) / NCD clinic for secondary prevention of stroke among stroke survivors.
Two hundred and eighty(n=280) adult patients with onset of stroke within 1 year of stroke and with severity of mRs < 4 will be enrolled from 9 stroke units of the state of Kerala. The primary outcome will be assessed as medication adherence. The Co-Primary outcome will be change in lifestyle and behavioral factors ,control of vascular risk factors and barriers and facilitators for risk factor monitoring in secondary stroke prevention. The secondary outcome will be proportion of participants willing for down referral to primary health centres (PHCs) from tertiary care centre,Vascular events namely TIA/Stroke/Cardiac events/Vascular deaths and functional outcome which will be assessed by mRS. The follow up will be done at the baseline, 3 month and 6 month. The data will be analyzed using appropriate statistical measures to determine efficacy of the mobile app in secondary prevention of stroke.
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
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients with onset of stroke within 3 years.
- •Severity:- (Modified Rankin Scale)mRS less than and equal to
- •Presence of one or more vascular risk factors such as hypertension, diabetes mellitus, smoking and dyslipidemia.
- •Patients who could understand the use of an Android-based smartphone.
排除标准
- •Patients with severe disability -modified Rankin Scale score greater than 4
- •Patients who do not consent.
- •Severe cognitive impairment.
- •Stroke survivors without a primary caregiver in patients with mRS-3 and 4.
结局指标
主要结局
Primary outcome:
时间窗: Baseline, Three months, Six months
1. Medication adherence
时间窗: Baseline, Three months, Six months
Co-Primary outcome
时间窗: Baseline, Three months, Six months
1. Changes in the lifestyle and behavioral factors.
时间窗: Baseline, Three months, Six months
2. Control of vascular risk factors measured at third and sixth months.
时间窗: Baseline, Three months, Six months
3. Barriers and facilitators for risk factor monitoring in the secondary prevention of stroke
时间窗: Baseline, Three months, Six months
次要结局
- 1. Proportion of participants willing for down referral to primary health center (PHCs) from tertiary care center.(2. Vascular events‑Myocardial infarction (MI)/Transient ischemic attack (TIA)/stroke/cardiac events/vascular deaths at third and sixth months.)
研究者
P N Sylaja
Sree Chitra Tirunal Institute for Medical Sciences and Technology,.