A Nurse-led Program for Stroke Patients

Not Applicable

• Conditions: Stroke; Psychosocial Problems
• Interventions: Other: Nurse- led program

• Registration Number: NCT05242536
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-01-23
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-05
• Last Update Submitted: 2022-02-05
• Study First Posted: 2022-02-16
• Last Update Posted: 2022-02-16
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse- led program	Nurse- led program	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.

Primary Outcome Measures

Name	Time	Method
Change in Pittsburgh Sleep Quality Index scores	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	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	At the baseline, 1st and 3rd month after discharge	Cognitive function will be evaluated by Montreal Cognitive Assessment Test.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stroke Center in Istinye University Liv Hospital-Bahcesehir; 🇹🇷 Istanbul, Turkey