Evaluation of comparative efficacy of newly developed P.W. Critical Care Pathway for stroke patients (PWCCPS) as against the London Stroke Careers Training Course for care givers regards to improvement of (FAST) outcome RCT
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome of this study is the improvement in stroke recovery, specifically focusing on the FAST (Facial drooping, Arm weakness, Speech difficulty, and Timely activities of daily living) components. These outcomes will be measured using the Cincinnati Pre-hospital Stroke Scale (CPSS). The effectiveness of the newly developed PW Critical Care Pathway will be compared with the London Stroke Carers Training Course to determine which intervention results in better stroke recovery.
研究概览
简要总结
This randomized controlled trial aims to evaluate the comparative efficacy of the newly developed P.W. Critical Care Pathway for stroke patients (PWCCPS) against the London Stroke Carers Training Course. The study focuses on improving stroke recovery outcomes, specifically FAST (Facial drooping, Arm weakness, Speech difficulty, and Timely activities of daily living) outcomes. Stroke patients and their primary caregivers will be enrolled, with assessments conducted at baseline, immediately after the intervention, and at a 3-month follow-up. The study will also assess the impact of these interventions on the patients’ physical, mental, and social well-being using standardized scales, including the Barthel Index, WHO Quality of Life Scale, and RACE scale. The findings will provide insights into the effectiveness of these care pathways in enhancing stroke recovery and overall quality of life.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •This study will include adult stroke patients aged 18 years and above who have been diagnosed within the last 72 hours and exhibit signs of facial drooping, arm weakness, or speech difficulty as assessed by the Cincinnati Pre-hospital Stroke Scale (CPSS).
- •The primary caregivers of these patients, who have been actively involved in daily care for at least one month and are willing to participate in the training and follow-up assessments, will also be included.
排除标准
- •Exclusion criteria include patients with a history of prior strokes, significant comorbidities, severe cognitive impairments, or those enrolled in conflicting clinical trials.
- •Caregivers who are professionally trained in stroke care, have substantial prior caregiving experience, or have severe health conditions preventing participation will also be excluded.
结局指标
主要结局
The primary outcome of this study is the improvement in stroke recovery, specifically focusing on the FAST (Facial drooping, Arm weakness, Speech difficulty, and Timely activities of daily living) components. These outcomes will be measured using the Cincinnati Pre-hospital Stroke Scale (CPSS). The effectiveness of the newly developed PW Critical Care Pathway will be compared with the London Stroke Carers Training Course to determine which intervention results in better stroke recovery.
时间窗: The primary outcome will be assessed at three specific time points: at baseline (before the intervention), at 4 weeks, and at 8 weeks post-intervention.
次要结局
- The secondary outcomes include the evaluation of physical, mental, and social parameters of stroke patients, assessed using the Barthel Index for daily living activities and the WHO Quality of Life Scale. These outcomes will compare the effectiveness of the P.W. Critical Care Pathway and the London Stroke Carers Training Course in improving overall well-being and functional independence of stroke patients. Additionally, the motor function of patients will be assessed using the RACE (Rapid Arterial oCclusion Evaluation) scale, with comparisons made between the two intervention groups.(Secondary outcomes will be assessed at baseline, immediately post-intervention (4-6 weeks after baseline), and at a 3-month follow-up.)
研究者
Pratibha Wankhede
Department of Community Health Nursing