UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050480 |
|---|---|
| Receipt number | R000057498 |
| Scientific Title | Evaluation of online simulation education on the active epidemiological investigation of COVID-19 among public health nursing students: a randomized controlled trial |
| Date of disclosure of the study information | 2023/03/03 |
| Last modified on | 2026/03/09 15:53:27 |
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Basic information
Public title
Evaluation of online simulation education on the active epidemiological investigation of COVID-19 among public health nursing students: a randomized controlled trial
Acronym
Evaluation of simulation education on active epidemiological investigation among public health nursing students: a randomized controlled trial
Scientific Title
Evaluation of online simulation education on the active epidemiological investigation of COVID-19 among public health nursing students: a randomized controlled trial
Scientific Title:Acronym
Evaluation of simulation education on active epidemiological investigation among public health nursing students: a randomized controlled trial
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to provide online simulation education for public health nursing students on the active epidemiological investigation of COVID-19 and to evaluate its effectiveness through a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Level of skill attainment for active epidemiological investigation of public health nursing students
Key secondary outcomes
The learning experience of COVID-19 in the active epidemiological investigation.
Knowledge of infection and COVID-19
Student satisfaction and self-confidence in learning
Free description
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Lecture and simulation
Interventions/Control_2
Lecture only
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Public health nursing students
Key exclusion criteria
A student who does not consent to participate in this study.
A student who has experienced active epidemiological investigation during their practical training.
A student at the university to which the simulation facilitator belongs.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Yoshimi |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Medical University
Division name
Faculty of Medicine, School of Nursing
Zip code
160-8402
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo
TEL
03-5357-7154
ysuzu@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Medical University
Division name
Faculty of Medicine, School of Nursing
Zip code
160-8402
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo
TEL
03-5357-7154
Homepage URL
ysuzu@tokyo-md.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japanese Red Cross College of Nursing, Shonan University of Medical Science, Bunri University of Hospitality
Name of secondary funder(s)
Not applicable.
IRB Contact (For public release)
Organization
Tokyo Medical University, Institutional Review Board
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo
Tel
03-5323-2027
adm_irb@tokyo-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/phn.70095
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/phn.70095
Number of participants that the trial has enrolled
59
Results
Compared to the control group, the intervention group demonstrated significant improvements in skills, knowledge, and overall learning outcomes related to PEI. They also demonstrated an enhanced understanding of key areas, including COVID-19risk factors and PEI methods, along with significantly higher levels of satisfaction and self-confidence in learning.
Results date posted
| 2026 | Year | 03 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We used a convenience sample of third- and fourth-year nursing university students enrolled in PHN courses in Japan because they represent the prelicensure phase, where foundational skills for public health practice, including PEI, are developed.
Participant flow
Faculty members at universities offering PHN programs were contacted individually through the researchers' professional networks. A request for participation in the study was first sent to the university department heads. If they agreed to cooperate, information about the study was shared with eligible students by PHN faculty members. Interested students registered online to participate in the study. Students were recruited from additional universities until the planned sample size was reached. Participation was voluntary and unrelated to academic evaluation.
Adverse events
No
Outcome measures
Level of skill attainment for active epidemiological investigation of public health nursing students
The learning experience of COVID-19 in the active epidemiological investigation.
Knowledge of infection and COVID-19
Student satisfaction and self-confidence in learning
Free description
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 03 | Day |
Last modified on
| 2026 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057498
