A Nurse-led Program for Stroke Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of a Nurse-led Program on Psychosocial Problems and Quality of Life in Stroke Patients

Conditions
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Stroke, Psychosocial Problems

Intervention / Treatment
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* Other: Nurse- led program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be literate Have a clinical diagnosis of ischemic stroke History of any preceding cerebral vascular event Capable of giving informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse- led program<br>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. | Other: Nurse- led program<br>* 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.<br>|
| No Intervention: Routine follow-up group<br>The control group will be applied usual care. Patients in the control group will be discharged by receiving standard care and performing discharge trainings used in the routine care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montreal Cognitive Assessment Test scores | Cognitive function will be evaluated by Montreal Cognitive Assessment Test. | At the baseline, 1st and 3rd month after discharge | 
| Change in Hospital Anxiety and Depression Scale scores | Anxiety and depression will be evaluated by Hospital Anxiety and Depression Scale. | At the baseline, 1st and 3rd month after discharge | 
| Change in Pittsburgh Sleep Quality Index scores | Sleep quality will be evaluated by Pittsburgh Sleep Quality Index. | At the baseline, 1st and 3rd month after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fatigue Severity Scale scores | Fatigue will be evaluated by Fatigue Severity Scale. | At the 1st and 3rd month after discharge | 
| Change in Reintegration to Normal Living Index scores | Adaptation to life will be evaluated by Reintegration to Normal Living Index. | At the 1st and 3rd month after discharge | 
| Change in Stroke Specific Quality of Life Scale scores | Quality of life will be evaluated by Stroke Specific Quality of Life Scale. | At the 1st and 3rd month after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Psychosocial Problem, Nurse-led Program, Quality of Life