A Nurse-led Program for Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242536
• Other study ID #: Nurse-led Program for Stroke
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: February 2022
• Source: Istanbul University-Cerrahpasa
• Contact: Hilalnur Kucukakgun, RN, MSc
• Phone: +905454229377
• Email: hilalnur.kucukakgun[@]iuc.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychosocial Problems
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Turkey	Stroke Center in Istinye University Liv Hospital-Bahcesehir	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa	Istinye University Liv Hospital-Bahcesehir, Stroke Center

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Lanctôt 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; Man — View 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. 2020 Nov 26:1-9. doi: 10.1080/09638288.2020.1849417. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in Fatigue Severity Scale scores	Fatigue will be evaluated by Fatigue Severity Scale.	At the 1st and 3rd month after discharge
Secondary	Change in Reintegration to Normal Living Index scores	Adaptation to life will be evaluated by Reintegration to Normal Living Index.	At the 1st and 3rd month after discharge
Secondary	Change in Stroke Specific Quality of Life Scale scores	Quality of life will be evaluated by Stroke Specific Quality of Life Scale.	At the 1st and 3rd month after discharge