The Effect of a Nurse-led Program on Psychosocial Problems and Quality of Life in Stroke Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Pittsburgh Sleep Quality Index scores
研究概览
简要总结
The aim of this study is to examine the effectiveness of nurse- led program on psychosocial problems and quality of life in stroke patients. This randomized controlled trial will be conducted in Stroke Center in Istinye University Liv Hospital-Bahcesehir. Eligible participants will be randomly allocated to either the control group (receiving usual care/ routine follow-up group) or the intervention group (receiving nurse-led psychosocial program). A nurse- led program will be implemented for the management of psychosocial problems following a comprehensive evaluation. Then, the effect of this program on psychosocial problems and quality of life will be evaluated in the 1st and 3rd months after discharge.
详细描述
The aim of this study is to examine the effectiveness of nurse- led program on psychosocial problems and quality of life in stroke patients. This randomized controlled trial will be conducted in Stroke Center in Istinye University Liv Hospital- Bahcesehir. Patients who meet the criteria will be randomized into the intervention group or control group. All patients will be assessed at discharge by use of following tools: National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale, Functional Independence Measure (FIM), Montreal Cognitive Assessment (MoCA), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI). A nurse coordinated multidisciplinary program aiming to improve psychosocial problems has been developed and will be applied to the patients in the experimental group. This nurse-led program will start at discharge and continue for three months. The control group will be applied usual care. Two groups will be compared at baseline and at the 3rd month after discharge in terms of psychosocial variables and quality of life.
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
- Single (Participant)
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
- •Be literate
- •Have a clinical diagnosis of ischemic stroke
- •History of any preceding cerebral vascular event
- •Capable of giving informed consent
排除标准
- •Age ≤ 18 years
- •Have a mental disorder that will prevent cognitive evaluation
- •Have an impaired consciousness (confusion, delirium, etc.)
- •History of any type of cognitive decline
- •Have severe neurologicial deficit
- •Severe aphasia
- •Living in a nursing home
- •Known malignant disease or other chronic disease with poor prognosis and a low life expectancy
结局指标
主要结局
Change in Pittsburgh Sleep Quality Index scores
时间窗: At the baseline, 1st and 3rd month after discharge
Sleep quality will be evaluated by Pittsburgh Sleep Quality Index.
Change in Hospital Anxiety and Depression Scale scores
时间窗: At the baseline, 1st and 3rd month after discharge
Anxiety and depression will be evaluated by Hospital Anxiety and Depression Scale.
Change in Montreal Cognitive Assessment Test scores
时间窗: At the baseline, 1st and 3rd month after discharge
Cognitive function will be evaluated by Montreal Cognitive Assessment Test.
次要结局
- Change in Fatigue Severity Scale scores(At the 1st and 3rd month after discharge)
- Change in Reintegration to Normal Living Index scores(At the 1st and 3rd month after discharge)
- Change in Stroke Specific Quality of Life Scale scores(At the 1st and 3rd month after discharge)
研究者
Zeliha Tülek
Assoc.Prof
Istanbul University - Cerrahpasa (IUC)