UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062854 |
|---|---|
| Receipt number | R000071742 |
| Scientific Title | A Prospective Observational Study of Changes in Hospital Notification Skills Following Repeated Use of a Web-Based Learning Support Application for Emergency Medical Technicians |
| Date of disclosure of the study information | 2026/09/09 |
| Last modified on | 2026/09/09 12:39:43 |
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Basic information
Public title
A Prospective Observational Study of Changes in Hospital Notification Skills Following Repeated Use of a Web-Based Learning Support Application for Emergency Medical Technicians
Acronym
A Prospective Observational Study of Changes in Hospital Notification Skills Following Repeated Use of a Web-Based Learning Support Application for Emergency Medical Technicians
Scientific Title
A Prospective Observational Study of Changes in Hospital Notification Skills Following Repeated Use of a Web-Based Learning Support Application for Emergency Medical Technicians
Scientific Title:Acronym
A Prospective Observational Study of Changes in Hospital Notification Skills Following Repeated Use of a Web-Based Learning Support Application for Emergency Medical Technicians
Region
| Japan |
Condition
Condition
Emergency medical illness
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate whether repeated use of the training mode leads to improvement in hospital communication skills, as reflected by AI-generated scores. Secondary objectives include assessing temporal changes in the completeness of SBAR/MIST reporting elements, comparing score trends across case categories, examining relationships between performance and participant characteristics or frequency of use, and evaluating the application's usability and acceptability.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Figure X. Changes in Overall Scores with Increasing Web Application Use
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Implementation of Education Using a Web Application
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study population will consist of EMS personnel from seven ambulance units of the Hakusan-Nonoichi Wide Area Fire Department. Study information will be provided individually by designated fire department personnel using materials and scripts prepared by the principal investigator. Consent forms will be submitted directly to the study office in sealed envelopes, and a minimum one-week consideration period will be ensured.
Inclusion criteria are: (1) assignment to one of the seven participating EMS units; (2) engagement in ambulance services; (3) certification as an EMT or completion of the Standard/Level II EMT training course; (4) ability to use a loaned device; and (5) provision of written informed consent.
Key exclusion criteria
Exclusion criteria are: (1) anticipated long-term leave or transfer during the study period; (2) no planned ambulance duty assignments; (3) involvement in application development or case creation; and (4) membership of the research team.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Takei |
Organization
Niigata University of Health and Welfare
Division name
Department of Emergency Medical Sciences
Zip code
9503198
Address
1398 Shimami, kita, Niigata city
TEL
+81252574644
yutaka-takei@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Takei |
Organization
Niigata University of Health and Welfare
Division name
Department of Emergency Medical Sciences
Zip code
9503198
Address
3198 Shimami, Kita, Niigata
TEL
+81252574644
Homepage URL
yutaka-takei@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Y Takei
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Niigata University of Health and Welfare
Address
3198 Shimami, Kita, Niigata
Tel
025-257-4455
yutaka-takei@nuhw.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
| 2026 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 09 | Day |
Last modified on
| 2026 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071742
