Acute StrokeNCT05462665
Evaluation of the Intravenous Tissue Plasminogen Activator Treatment Algorithm of Nursing Intern Students
A study testing theory training and theory and simulation training in people with Acute Stroke, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Intravenous (IV) tissue plasminogen activator (tPA) is one of the key elements of acute ischemic stroke. In this study, acute stroke patients maximum benefit from the treatment, intravenous tissue plasminogen activator (IV tPA) minimizing the errors related to the treatment of acute ischemic stroke patients of nursing… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- theory training and theory and simulation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 1 Mar 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 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Intern nursing student at Dokuz Eylül University
Who cannot join
- Those who did not agree to participate in the study Those who were not be intern
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Intravenous Tissue Plasminogen Activator Treatment Algorithm of Nursing Intern Students and Evaluation of the Efficiency of Simulation Method in the Development of Self-Efficacy Proficiency Levels
Intravenous (IV) tissue plasminogen activator (tPA) is one of the key elements of acute ischemic stroke. In this study, acute stroke patients maximum benefit from the treatment, intravenous tissue plasminogen activator (IV tPA) minimizing the errors related to the treatment of acute ischemic stroke patients of nursing students from clinical practice guides published on the treatment of It is aimed to be informed and to standardize nursing interventions.
Read the detailed description
Time management in acute stroke patients is possible with a multidisciplinary approach and team members who have received specific training for acute stroke patients. Studies have shown that the maximum result of treatment for acute stroke patients depends on nurses' ability to identify disease symptoms, plan and apply symptom-specific nursing care. There is evidence that the multidisciplinary presence of stroke teams in stroke units and the delivery of coordinated care during the acute phase improve patient outcomes . Coordinated care by the stroke team improves patient outcomes, reduces hospital costs, reduces patient readmission, and improves patient care quality.
- Conditions
- Acute Stroke
- Being tested
- theory training, theory and simulation training
- Keywords
- tissue plasminogen activator, acute stroke, intravenous tissue plasminogen activator, nursing care, neurology nursing, acute stroke treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theory trainingBehavioural
Also called tPA treatment knowledge of nursing students will increase
theory training
theory and simulation trainingBehavioural
Also called tPA treatment knowledge of nursing students will increase
theory and simulation training
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Nursing intern students (n:39) will be given theory training about tPA treatment Receives: Behavioral: theory training |
| Control | Experimental | Nursing intern students (n:39) will be given theory training and simulation training about tPA treatment Receives: Behavioral: theory training; Behavioral: theory and simulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-efficacy scale
Effectiveness change of Intravenous tissue plasminogen activator treatment knowledge after theoric teaching
Measured: Change from baseline in Intravenous Tissue Plasminogen Activator Treatment knowledge and 2 weeks after intervention
simulation scale
evaluation the simulation design
Measured: 2 weeks after simulation training
tPA treatment information form
Effectiveness change of Intravenous tissue plasminogen activator treatment knowledge after simulation and theoric teaching
Measured: Change from baseline in Intravenous Tissue Plasminogen Activator Treatment knowledge and 2 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 May 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intern nurses will be numbered from 1 to 75 and will be randomly divided into study and control groups from the random numbers table. After the groups are determined by the randomization method, each intern nurse in the study and control groups will be interviewed face to face and their written informed consent will be obtained. Then, all nursing intern students participating in the research will be asked to fill in the IV tPA Treatment Knowledge Level Evaluation Form, Self-Efficacy Competence Scale. Intern nurses in both groups will be given 1-hour theoretical training on IV tPA treatment before, during and after the procedure. In addition, simulation-based training will be applied to the intern nurses in the study group regarding IV tPA treatment before, during and after the procedure.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OZGE SOYDANER, Dokuz Eylul University
- Investigators
- GULSAH GUROL ARSLAN, Study director, DOKUZ EU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462665
- Sponsor's protocol ID
- tPA Treatment
- Status last verified
- Dec 2021
- First submitted
- 23 Mar 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Intravenous Tissue Plasminogen Activator Treatment Algorithm of Nursing Intern Students and Evaluation of the Efficiency of Simulation Method in the Development of Self-Efficacy Proficiency Levels
- ClinicalTrials.gov ID
- NCT05462665
- Acronym / sponsor ID
- tPA Treatment
- Conditions
- Acute Stroke
- Keywords
- tissue plasminogen activator, acute stroke, intravenous tissue plasminogen activator, nursing care, neurology nursing, acute stroke treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 18 Jul 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.
Intravenous (IV) tissue plasminogen activator (tPA) is one of the key elements of acute ischemic stroke. In this study, acute stroke patients maximum benefit from the treatment, intravenous tissue plasminogen activator (IV tPA) minimizing the errors related to the treatment of acute ischemic stroke patients of nursing students from clinical practice guides published on the treatment of It is aimed to be informed and to standardize nursing interventions.
Detailed description
Time management in acute stroke patients is possible with a multidisciplinary approach and team members who have received specific training for acute stroke patients. Studies have shown that the maximum result of treatment for acute stroke patients depends on nurses' ability to identify disease symptoms, plan and apply symptom-specific nursing care. There is evidence that the multidisciplinary presence of stroke teams in stroke units and the delivery of coordinated care during the acute phase improve patient outcomes . Coordinated care by the stroke team improves patient outcomes, reduces hospital costs, reduces patient readmission, and improves patient care quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intern nurses will be numbered from 1 to 75 and will be randomly divided into study and control groups from the random numbers table. After the groups are determined by the randomization method, each intern nurse in the study and control groups will be interviewed face to face and their written informed consent will be obtained. Then, all nursing intern students participating in the research will be asked to fill in the IV tPA Treatment Knowledge Level Evaluation Form, Self-Efficacy Competence Scale. Intern nurses in both groups will be given 1-hour theoretical training on IV tPA treatment before, during and after the procedure. In addition, simulation-based training will be applied to the intern nurses in the study group regarding IV tPA treatment before, during and after the procedure.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: theory trainingNursing intern students (n:39) will be given theory training about tPA treatment |
| Control | Experimental | Behavioral: theory training, Behavioral: theory and simulation trainingNursing intern students (n:39) will be given theory training and simulation training about tPA treatment |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Intern nursing student at Dokuz Eylül University
Key exclusion criteria (1 listed)
- Those who did not agree to participate in the study Those who were not be intern
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 |
|---|---|---|
| theory trainingAlso: tPA treatment knowledge of nursing students will increasetheory training | Behavioural | Control, intervention |
| theory and simulation trainingAlso: tPA treatment knowledge of nursing students will increasetheory and simulation training | Behavioural | Control |
Primary outcome
self-efficacy scale
Time frame: Change from baseline in Intravenous Tissue Plasminogen Activator Treatment knowledge and 2 weeks after intervention
Effectiveness change of Intravenous tissue plasminogen activator treatment knowledge after theoric teaching
simulation scale
Time frame: 2 weeks after simulation training
evaluation the simulation design
tPA treatment information form
Time frame: Change from baseline in Intravenous Tissue Plasminogen Activator Treatment knowledge and 2 weeks after intervention
Effectiveness change of Intravenous tissue plasminogen activator treatment knowledge after simulation and theoric teaching
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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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.
GULSAH GUROL ARSLAN study director
DOKUZ EU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing theory training and theory and simulation training in people with Acute Stroke, run by Dokuz Eylul University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-efficacy scale (time frame: Change from baseline in Intravenous Tissue Plasminogen Activator Treatment knowledge and 2 weeks after intervention). 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?
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 18 Jul 2022.