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A Nurse-led Program for Stroke Patients

Primary Purpose

Stroke, Psychosocial Problems

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nurse- led program
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Stroke, Psychosocial Problem, Nurse-led Program, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stroke Center in Istinye University Liv Hospital-BahcesehirRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nurse- led program

Routine follow-up group

Arm Description

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. Patients in the control group will be discharged by receiving standard care and performing discharge trainings used in the routine care.

Outcomes

Primary Outcome Measures

Change in Montreal Cognitive Assessment Test scores
Cognitive function will be evaluated by Montreal Cognitive Assessment Test.
Change in Hospital Anxiety and Depression Scale scores
Anxiety and depression will be evaluated by Hospital Anxiety and Depression Scale.
Change in Pittsburgh Sleep Quality Index scores
Sleep quality will be evaluated by Pittsburgh Sleep Quality Index.

Secondary Outcome Measures

Change in Fatigue Severity Scale scores
Fatigue will be evaluated by Fatigue Severity Scale.
Change in Reintegration to Normal Living Index scores
Adaptation to life will be evaluated by Reintegration to Normal Living Index.
Change in Stroke Specific Quality of Life Scale scores
Quality of life will be evaluated by Stroke Specific Quality of Life Scale.

Full Information

First Posted
January 23, 2022
Last Updated
February 5, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Istinye University Liv Hospital-Bahcesehir, Stroke Center
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1. Study Identification

Unique Protocol Identification Number
NCT05242536
Brief Title
A Nurse-led Program for Stroke Patients
Official Title
The Effect of a Nurse-led Program on Psychosocial Problems and Quality of Life in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Istinye University Liv Hospital-Bahcesehir, Stroke Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Psychosocial Problems
Keywords
Stroke, Psychosocial Problem, Nurse-led Program, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nurse- led program
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine follow-up group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nurse- led program
Intervention Description
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 Measure Information:
Title
Change in Montreal Cognitive Assessment Test scores
Description
Cognitive function will be evaluated by Montreal Cognitive Assessment Test.
Time Frame
At the baseline, 1st and 3rd month after discharge
Title
Change in Hospital Anxiety and Depression Scale scores
Description
Anxiety and depression will be evaluated by Hospital Anxiety and Depression Scale.
Time Frame
At the baseline, 1st and 3rd month after discharge
Title
Change in Pittsburgh Sleep Quality Index scores
Description
Sleep quality will be evaluated by Pittsburgh Sleep Quality Index.
Time Frame
At the baseline, 1st and 3rd month after discharge
Secondary Outcome Measure Information:
Title
Change in Fatigue Severity Scale scores
Description
Fatigue will be evaluated by Fatigue Severity Scale.
Time Frame
At the 1st and 3rd month after discharge
Title
Change in Reintegration to Normal Living Index scores
Description
Adaptation to life will be evaluated by Reintegration to Normal Living Index.
Time Frame
At the 1st and 3rd month after discharge
Title
Change in Stroke Specific Quality of Life Scale scores
Description
Quality of life will be evaluated by Stroke Specific Quality of Life Scale.
Time Frame
At the 1st and 3rd month after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hilalnur Kucukakgun, RN, MSc
Phone
+905454229377
Email
hilalnur.kucukakgun@iuc.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Zeliha Tulek, RN, PhD
Phone
902122242618
Ext
27254
Email
ztulek@iuc.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilalnur Kucukakgun, RN,MSc
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zeliha Tulek, RN,Assoc Prof
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yakup Krespi, MD, Prof
Organizational Affiliation
Istinye University Liv Hospital- Bahcesehir
Official's Role
Study Chair
Facility Information:
Facility Name
Stroke Center in Istinye University Liv Hospital-Bahcesehir
City
Istanbul
ZIP/Postal Code
34510
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilalnur Kucukakgun, RN, MSc
Phone
05454229377
Email
hilalnur.kucukakgun@iuc.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33242261
Citation
Verberne DPJ, Kroese MEAL, Staals J, Ponds RWHM, van Heugten CM. Nurse-led stroke aftercare addressing long-term psychosocial outcome: a comparison to care-as-usual. Disabil Rehabil. 2022 Jun;44(12):2849-2857. doi: 10.1080/09638288.2020.1849417. Epub 2020 Nov 26.
Results Reference
background
PubMed Identifier
31221036
Citation
Lanctot KL, Lindsay MP, Smith EE, Sahlas DJ, Foley N, Gubitz G, Austin M, Ball K, Bhogal S, Blake T, Herrmann N, Hogan D, Khan A, Longman S, King A, Leonard C, Shoniker T, Taylor T, Teed M, de Jong A, Mountain A, Casaubon LK, Dowlatshahi D, Swartz RH; Management of Mood, Cognition and Fatigue Following Stroke Best Practice Writing Group, the Heart & Stroke Canadian Stroke Best Practices and Quality Advisory Committee; in collaboration with the Canadian Stroke Consortium. Canadian Stroke Best Practice Recommendations: Mood, Cognition and Fatigue following Stroke, 6th edition update 2019. Int J Stroke. 2020 Aug;15(6):668-688. doi: 10.1177/1747493019847334. Epub 2019 Jun 21.
Results Reference
result

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A Nurse-led Program for Stroke Patients

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