Essential Acute Stroke Care in Low Resource Settings: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Adherence
研究概览
简要总结
An investigator-initiated, evaluator-blinded, prospective, multi centre, before-and-after, effectiveness-implementation hybrid design study to assess the feasibility of essential acute stroke care in a low resource setting
详细描述
This is a multicentre, before and after, effectiveness-implementation hybrid study design with blinded outcome assessment. Patients admitted to the participating hospitals will be managed under usual care conditions for three months (control arm). This will be followed by the training of the doctors and nurses in those hospitals on essential acute stroke care management. Patient management for the following three months after the training (intervention) will then be assessed to evaluate its impact on the care and clinical outcome of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinical outcome will be assessed by a blinded 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
- •Adults (age ≥18 years)
- •A clinical or imaging-based diagnosis of acute stroke (ischemic or haemorrhagic) within 72 hours of stroke symptom onset
- •Provision of written informed consent
- •Subjects in observational, natural history and/or epidemiological studies not involving an intervention are eligible.
排除标准
- •Patients who have undergone intravenous thrombolysis or mechanical thrombectomy
- •Patients who are planned for transfer to the intensive care unit
- •Subarachnoid haemorrhage
- •Participation in an interventional medical investigation or clinical trial currently or within the past 3 months.
研究组 & 干预措施
Usual Care
Usual care to be provided to patients as per hospital guidelines for 3 months
Intervention arm
The intervention consists of training and education of the site staff about the treatment protocol for the different components of the management plan will be provided on two occasions. This intervention will run for 3 months.
Refresher training will be given monthly during the intervention.
干预措施: Acute stroke care Intervention arm (Other)
结局指标
主要结局
Adherence
时间窗: 30 days
Primary Outcome Measure: Adherence to the predefined components of the essential acute stroke care management plan Adherence will be expressed as all or none measure and is defined as the proportion of patients who receive all the components of acute stroke care management for which the patient is eligible. Adherence will also be expressed as a composite measure, which is defined as the total number of eligible components performed divided by the total number of components for which the patient was eligible.
次要结局
- Death or disability(30 Days)