NCT05462665

Brief 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 students from clinical practice guides published on the treatment of It is aimed to be informed and to standardize nursing interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
Last Updated

July 18, 2022

Status Verified

December 1, 2021

Enrollment Period

1.8 years

First QC Date

March 23, 2022

Last Update Submit

July 15, 2022

Conditions

Acute Stroke

Keywords

tissue plasminogen activatoracute strokeintravenous tissue plasminogen activatornursing careneurology nursingacute stroke treatment

Outcome Measures

Primary Outcomes (3)

  • self-efficacy scale

    Effectiveness change of Intravenous tissue plasminogen activator treatment knowledge after theoric teaching

    Change from baseline in Intravenous Tissue Plasminogen Activator Treatment knowledge and 2 weeks after intervention

  • simulation scale

    evaluation the simulation design

    2 weeks after simulation training

  • tPA treatment information form

    Effectiveness change of Intravenous tissue plasminogen activator treatment knowledge after simulation and theoric teaching

    Change from baseline in Intravenous Tissue Plasminogen Activator Treatment knowledge and 2 weeks after intervention

Study Arms (2)

intervention

EXPERIMENTAL

Nursing intern students (n:39) will be given theory training about tPA treatment

Behavioral: theory training

Control

EXPERIMENTAL

Nursing intern students (n:39) will be given theory training and simulation training about tPA treatment

Behavioral: theory trainingBehavioral: theory and simulation training

Interventions

theory trainingBEHAVIORAL

theory training

Also known as: tPA treatment knowledge of nursing students will increase
Controlintervention
theory and simulation trainingBEHAVIORAL

theory and simulation training

Also known as: tPA treatment knowledge of nursing students will increase
Control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Intern nursing student at Dokuz Eylül University

You may not qualify if:

  • Those who did not agree to participate in the study Those who were not be intern

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozge Soydaner

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • GULSAH GUROL ARSLAN

    DOKUZ EU

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
nurse

Study Record Dates

First Submitted

March 23, 2022

First Posted

July 18, 2022

Study Start

May 1, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

July 18, 2022

Record last verified: 2021-12

Locations

TU(1)