Skip to main content
Clinical Trials/NCT05242536
NCT05242536
Unknown
N/A

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

Istanbul University - Cerrahpasa (IUC)1 site in 1 country70 target enrollmentNovember 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
70
Locations
1
Primary Endpoint
Change in Pittsburgh Sleep Quality Index scores
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
November 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Zeliha Tülek

Assoc.Prof

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Pittsburgh Sleep Quality Index scores

Time Frame: 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

Time Frame: 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

Time Frame: At the baseline, 1st and 3rd month after discharge

Cognitive function will be evaluated by Montreal Cognitive Assessment Test.

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials