A Nurse-led Program for Stroke Patients

February 5, 2022 updated by: Zeliha Tülek, Istanbul University - Cerrahpasa (IUC)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zeliha Tulek, RN, PhD
  • Phone Number: 27254 902122242618
  • Email: ztulek@iuc.edu.tr

Study Locations

  • Turkey
      • Istanbul, Turkey, 34510
        • Recruiting
        • Stroke Center in Istinye University Liv Hospital-Bahcesehir
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: Routine follow-up group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the baseline, 1st and 3rd month after discharge
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.
At the baseline, 1st and 3rd month after discharge
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.
At the baseline, 1st and 3rd month after discharge

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Collaborators

Istinye University Liv Hospital-Bahcesehir, Stroke Center

Investigators

  • Principal Investigator: Hilalnur Kucukakgun, RN,MSc, Istanbul University - Cerrahpasa (IUC)
  • Study Director: Zeliha Tulek, RN,Assoc Prof, Istanbul University - Cerrahpasa (IUC)
  • Study Chair: Yakup Krespi, MD, Prof, Istinye University Liv Hospital- Bahcesehir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

January 23, 2022

First Submitted That Met QC Criteria

February 5, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 5, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nurse-led Program for Stroke

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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