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A Nurse-led Program for Stroke Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05242536
Enrollment
70
Registered
2022-02-16
Start date
2021-11-01
Completion date
2022-11-01
Last updated
2022-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosocial Problems, Stroke

Keywords

Stroke, Psychosocial Problem, Nurse-led Program, Quality of Life

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.

Interventions

OTHERNurse- 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.

Sponsors

Istinye University
CollaboratorOTHER
Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Pittsburgh Sleep Quality Index scoresAt the baseline, 1st and 3rd month after dischargeSleep quality will be evaluated by Pittsburgh Sleep Quality Index.
Change in Hospital Anxiety and Depression Scale scoresAt the baseline, 1st and 3rd month after dischargeAnxiety and depression will be evaluated by Hospital Anxiety and Depression Scale.
Change in Montreal Cognitive Assessment Test scoresAt the baseline, 1st and 3rd month after dischargeCognitive function will be evaluated by Montreal Cognitive Assessment Test.

Secondary

MeasureTime frameDescription
Change in Fatigue Severity Scale scoresAt the 1st and 3rd month after dischargeFatigue will be evaluated by Fatigue Severity Scale.
Change in Reintegration to Normal Living Index scoresAt the 1st and 3rd month after dischargeAdaptation to life will be evaluated by Reintegration to Normal Living Index.
Change in Stroke Specific Quality of Life Scale scoresAt the 1st and 3rd month after dischargeQuality of life will be evaluated by Stroke Specific Quality of Life Scale.

Countries

Turkey (Türkiye)

Contacts

Primary ContactHilalnur Kucukakgun, RN, MSc
hilalnur.kucukakgun@iuc.edu.tr+905454229377
Backup ContactZeliha Tulek, RN, PhD
ztulek@iuc.edu.tr902122242618

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026