Clinical trial NCT05242536: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Psychosocial Problems
Keywords: Stroke
Psychosocial Problem
Nurse-led Program
Quality of Life
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Istinye University
First posted: 2022-02-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Montreal Cognitive Assessment Test scores
timeFrame: At the baseline, 1st and 3rd month after discharge
measure: Change in Hospital Anxiety and Depression Scale scores
timeFrame: At the baseline, 1st and 3rd month after discharge
measure: Change in Pittsburgh Sleep Quality Index scores
timeFrame: At the baseline, 1st and 3rd month after discharge
Secondary outcomes:
measure: Change in Fatigue Severity Scale scores
timeFrame: At the 1st and 3rd month after discharge
measure: Change in Reintegration to Normal Living Index scores
timeFrame: At the 1st and 3rd month after discharge
measure: Change in Stroke Specific Quality of Life Scale scores
timeFrame: At the 1st and 3rd month after discharge
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Stroke Center in Istinye University Liv Hospital-Bahcesehir
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Hilalnur Kucukakgun, RN,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Zeliha Tulek, RN,Assoc Prof
role: STUDY_DIRECTOR
affiliation: Istinye University Liv Hospital- Bahcesehir
name: Yakup Krespi, MD, Prof
role: STUDY_CHAIR
References:
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.
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.