StrokeNCT05242536
A Nurse-led Program for Stroke Patients
A study testing Nurse- led program in people with Stroke and Psychosocial Problems, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Psychosocial Problems
- What is being tested?
- Nurse- led program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be literate
- Have a clinical diagnosis of ischemic stroke
- History of any preceding cerebral vascular event
- Capable of giving informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Stroke Center in Istinye University Liv Hospital-Bahcesehir
Istanbul, 34510
Hilalnur Kucukakgun, RN, MSc, 05454229377, hilalnur.kucukakgun@iuc.edu.tr
About this study
Official title: The Effect of a Nurse-led Program on Psychosocial Problems and Quality of Life in Stroke Patients
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.
Read the 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.
- Conditions
- Stroke, Psychosocial Problems
- Being tested
- Nurse- led program
- Keywords
- Stroke, Psychosocial Problem, Nurse-led Program, Quality of Life
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse- led programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nurse- led program | Experimental | 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. Receives: Other: Nurse- led program |
| Routine follow-up group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montreal Cognitive Assessment Test scores
Cognitive function will be evaluated by Montreal Cognitive Assessment Test.
Measured: 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.
Measured: 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.
Measured: At the baseline, 1st and 3rd month after discharge
Secondary outcomes (3)
Change in Fatigue Severity Scale scores
Fatigue will be evaluated by Fatigue Severity Scale.
Measured: At the 1st and 3rd month after discharge
Change in Reintegration to Normal Living Index scores
Adaptation to life will be evaluated by Reintegration to Normal Living Index.
Measured: At the 1st and 3rd month after discharge
Change in Stroke Specific Quality of Life Scale scores
Quality of life will be evaluated by Stroke Specific Quality of Life Scale.
Measured: At the 1st and 3rd month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Nov 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Istinye University
- Responsible party
- Principal investigator, Zeliha Tülek, Istanbul University - Cerrahpasa
- Investigators
- Hilalnur Kucukakgun, RN,MSc, Principal investigator, Istanbul University - CerrahpasaZeliha Tulek, RN,Assoc Prof, Study director, Istanbul University - CerrahpasaYakup Krespi, MD, Prof, Study chair, Istinye University Liv Hospital- Bahcesehir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242536
- Sponsor's protocol ID
- Nurse-led Program for Stroke
- Status last verified
- Feb 2022
- First submitted
- 23 Jan 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33242261Lanctot 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.
PubMed 31221036
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nurse-led Program on Psychosocial Problems and Quality of Life in Stroke Patients
- ClinicalTrials.gov ID
- NCT05242536
- Acronym / sponsor ID
- Nurse-led Program for Stroke
- Conditions
- Stroke, Psychosocial Problems
- Keywords
- Stroke, Psychosocial Problem, Nurse-led Program, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Istinye University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse- led program | Experimental | Other: Nurse- led programA 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 intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be literate
- Have a clinical diagnosis of ischemic stroke
- History of any preceding cerebral vascular event
- Capable of giving informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse- led programA 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. | Other | Nurse- led program |
Primary outcome
Change in Montreal Cognitive Assessment Test scores
Time frame: At the baseline, 1st and 3rd month after discharge
Cognitive function will be evaluated by Montreal Cognitive Assessment Test.
Change in Hospital Anxiety and Depression Scale scores
Time frame: At the baseline, 1st and 3rd month after discharge
Anxiety and depression will be evaluated by Hospital Anxiety and Depression Scale.
Change in Pittsburgh Sleep Quality Index scores
Time frame: At the baseline, 1st and 3rd month after discharge
Sleep quality will be evaluated by Pittsburgh Sleep Quality Index.
3 secondary outcomes
Change in Fatigue Severity Scale scores
Time frame: At the 1st and 3rd month after discharge
Change in Reintegration to Normal Living Index scores
Time frame: At the 1st and 3rd month after discharge
Change in Stroke Specific Quality of Life Scale scores
Time frame: At the 1st and 3rd month after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Background: PubMed 33242261Verberne 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.
- Results publication: PubMed 31221036Lanctot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilalnur Kucukakgun, RN,MSc principal investigator
Istanbul University - Cerrahpasa
Zeliha Tulek, RN,Assoc Prof study director
Istanbul University - Cerrahpasa
Yakup Krespi, MD, Prof study chair
Istinye University Liv Hospital- Bahcesehir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse- led program in people with Stroke and Psychosocial Problems, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilalnur Kucukakgun, RN, MSc (+905454229377, hilalnur.kucukakgun@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment Test scores (time frame: At the baseline, 1st and 3rd month after discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05242536, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.