A Nurse-led Program for Stroke Patients

NCT ID: NCT05242536

Last Updated: 2022-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-11-01

Brief Summary

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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

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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.

Conditions

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Stroke Psychosocial Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Nurse- led program

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istinye University

OTHER

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Zeliha Tülek

Assoc.Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hilalnur Kucukakgun, RN,MSc

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Zeliha Tulek, RN,Assoc Prof

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Yakup Krespi, MD, Prof

Role: STUDY_CHAIR

Istinye University Liv Hospital- Bahcesehir

Locations

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Stroke Center in Istinye University Liv Hospital-Bahcesehir

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hilalnur Kucukakgun, RN, MSc

Role: CONTACT

+905454229377

Zeliha Tulek, RN, PhD

Role: CONTACT

902122242618 ext. 27254

Facility Contacts

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Hilalnur Kucukakgun, RN, MSc

Role: primary

05454229377

References

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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.

Reference Type BACKGROUND
PMID: 33242261 (View on PubMed)

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.

Reference Type RESULT
PMID: 31221036 (View on PubMed)

Other Identifiers

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Nurse-led Program for Stroke

Identifier Type: -

Identifier Source: org_study_id

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