UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000059240
Receipt number R000067757
Scientific Title Evaluation of the Educational Effectiveness of Kampo Medicine Learning Materials for Junior Residents
Date of disclosure of the study information 2025/10/01
Last modified on 2025/09/30 12:32:23

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Basic information

Public title

Evaluation of the Educational Effectiveness of Kampo Medicine Learning Materials for Junior Residents

Acronym

Evaluation of the Educational Effectiveness of Kampo Medicine Learning Materials for Junior Residents

Scientific Title

Evaluation of the Educational Effectiveness of Kampo Medicine Learning Materials for Junior Residents

Scientific Title:Acronym

EEE-Kampo JR

Region

Japan


Condition

Condition

This study does not involve patients.

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to verify the educational effectiveness of original e-learning video materials on Kampo medicine for junior residents and supervising physicians.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The difference in scores between pre-tests and post-tests administered to junior residents before and after using the educational materials.

Key secondary outcomes

1. Subgroup analysis of score differences in pre- and post-tests of junior residents based on the sequence of material usage. 2. Utilization metrics of the materials. 3. Score differences in pre- and post-tests of supervising physicians before and after using the materials. 4. Correlation between test score differences (pre/post) and participants' background information as well as utilization metrics. 5. Evaluation of materials through post-use questionnaires.


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

Participants will be provided with video-based teaching materials and asked to use them for self-directed learning during a one-month training period. The video materials, developed by the principal investigator, will cover both general and specific topics in Kampo medicine. Participants will access and view these materials on a dedicated website.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Junior residents (PGY1,2)or supervising physicians (PGY3 or higher) who can be recruited at the participating institutions.
2. Study participants who provide informed consent.

Key exclusion criteria

None.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Kazushi
Middle name
Last name Uneda

Organization

Aizu Medical Center, Fukushima Medical University

Division name

Department of Kampo Medicine

Zip code

969-3492

Address

21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima

TEL

+81-242-75-2100

Email

uneda@fmu.ac.jp


Public contact

Name of contact person

1st name Kazushi
Middle name
Last name Uneda

Organization

Aizu Medical Center, Fukushima Medical University

Division name

Department of Kampo Medicine

Zip code

969-3492

Address

21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima

TEL

+81-242-75-2100

Homepage URL


Email

uneda@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

Japan Kampo Medicine Education Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukushima Medical University Ethics Committee

Address

1 Hikariga-oka, Fukushima, Fukushima 960-1295, Japan

Tel

024-547-1111

Email

fmurec@fmu.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

福島県立医科大学会津医療センター(福島県)、富山大学附属病院(富山県)、横浜市立大学附属病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2025 Year 10 Month 01 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

2025 Year 09 Month 22 Day

Date of IRB

2025 Year 09 Month 22 Day

Anticipated trial start date

2025 Year 11 Month 01 Day

Last follow-up date

2026 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 09 Month 30 Day

Last modified on

2025 Year 09 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067757