A Nurse-led Program for Stroke Patients
The Effect of a Nurse-led Program on Psychosocial Problems and Quality of Life in Stroke Patients
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 23, 2022
CompletedFirst Posted
Study publicly available on registry
February 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedFebruary 16, 2022
February 1, 2022
1 year
January 23, 2022
February 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
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 Arms (2)
Nurse- led program
EXPERIMENTALA 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.
Routine follow-up group
NO INTERVENTIONThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Be literate
- Have a clinical diagnosis of ischemic stroke
- History of any preceding cerebral vascular event
- Capable of giving informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istanbul University - Cerrahpasalead
- Istinye Universitycollaborator
Study Sites (1)
Stroke Center in Istinye University Liv Hospital-Bahcesehir
Istanbul, 34510, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 33242261BACKGROUNDLanctot 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.
PMID: 31221036RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hilalnur Kucukakgun, RN,MSc
Istanbul University - Cerrahpasa
- STUDY DIRECTOR
Zeliha Tulek, RN,Assoc Prof
Istanbul University - Cerrahpasa
- STUDY CHAIR
Yakup Krespi, MD, Prof
Istinye University Liv Hospital- Bahcesehir
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc.Prof
Study Record Dates
First Submitted
January 23, 2022
First Posted
February 16, 2022
Study Start
November 1, 2021
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
February 16, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share