UMIN-ICDS Clinical Trial

Public title

Learning pediatric home-care support through CareLabo: an evaluation in medical students

Acronym

CareLabo Medical Student Study

Scientific Title

Educational evaluation of gamification-based training for pediatric home-care support during pediatric clinical clerkships: a single-arm pre-post study

Scientific Title:Acronym

CareLabo Medical Student Study

Region

Japan

Condition

Medical student education in pediatric home-care support. Participants are fifth-year medical students, not pediatric patients.

Classification by specialty

Pediatrics

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the change in knowledge test scores immediately before and after gamification-based training in pediatric home-care support during fifth-year pediatric clinical clerkships at Shinshu University School of Medicine. Secondary objectives are to assess understanding of support professionals' roles, satisfaction and acceptability, free-text feedback, and implementation.

Basic objectives2

Others

Basic objectives -Others

Educational evaluation

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Change in knowledge test score (0-15 points), calculated as the immediately post-training score minus the immediately pre-training score. Each form has 15 items worth one point each. Parallel forms A and B are alternated between the pre- and post-training assessments, immediately before and after the approximately 3-hour training session.

Key secondary outcomes

Pre- to post-training change in understanding of the roles of six support professions, each rated on a five-point scale. Immediately post-training satisfaction and acceptability (seven items, five-point scales), elements perceived as useful for learning, and free-text feedback. Implementation measures for each session include participant count, duration, facilitators, material version, deviations, and problems.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Participants receive approximately 3 hours of CareLabo training within the regular pediatric clerkship. This group exercise simulates the first month at home after discharge, with participants taking the roles of parents and six support professions. Research participation does not alter regular teaching or access to training. After written consent, participants complete a questionnaire and a 15-item multiple-choice knowledge test using a research ID immediately before and after training, requiring approximately 10-12 minutes at each time point. A-to-B and B-to-A test sequences are used in approximately equal numbers within each session. Scores and correct answers are not shown immediately after submission.

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Fifth-year medical students at Shinshu University School of Medicine who attend CareLabo during their pediatric clinical clerkship and provide written informed consent. Participants are adults and provide consent on their own behalf.

Key exclusion criteria

Students who do not consent to participate or who withdraw their consent.

Target sample size

120

Name of lead principal investigator

1st name	Yukihide
Middle name
Last name	Miyosawa

Organization

Shinshu University School of Medicine

Division name

Department of Pediatrics

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2642

Email

miyosawa@shinshu-u.ac.jp

Name of contact person

1st name	Yukihide
Middle name
Last name	Miyosawa

Organization

Shinshu University School of Medicine

Division name

Department of Pediatrics

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2642

Homepage URL

Email

miyosawa@shinshu-u.ac.jp

Institute

Shinshu University

Institute

Department

Personal name

Organization

Kawano Masanori Memorial Public Interest Incorporated Foundation for Promotion of Pediatrics

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Shinshu University School of Medicine Biological and Medical Research Ethics Committee

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

Tel

0263-37-3099

Email

mdrinri@shinshu-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

信州大学医学部（長野県）

Date of disclosure of the study information

2026

Year

11

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

No plan to share individual participant data outside the study institution. Only aggregate findings will be published.

IPD sharing Plan description

Data are stored in a dedicated university-managed folder. Until grades are finalized, only the designated physician who is not involved in grading manages and accesses consent records, the ID linkage table, and responses. After grade finalization, analysis data without direct identifiers are provided to the principal investigator. Records are retained for 10 years after final publication. Secondary use outside this protocol is not planned.

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

10

Month

07

Day

Date of IRB

2026

Year

11

Month

03

Day

Anticipated trial start date

2026

Year

11

Month

19

Day

Last follow-up date

2027

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Regular education is unchanged by research participation. Participation is voluntary and does not affect clerkship assessment, grades, or progression. Individual scores and analyses are not returned. The primary analysis includes valid paired responses under the same research ID. Mean score change, standard deviation, 95% confidence interval, a paired t test, and a standardized paired effect size will be reported. If markedly skewed, a Wilcoxon signed-rank test will be added as a sensitivity analysis. Test sequences are described separately; missing data are not imputed. CareLabo was developed by Medical Gamification Labo M-terrace, a general incorporated association whose representative director is the principal investigator. The association does not fund this study, which is not a joint or commissioned research project. The funding foundation has no role in study design, conduct, analysis, or publication. Enrollment ends by 30 September 2027; the overall study period ends by 31 March 2028. Institutional application: 2026-163; study number: 6998. Ethics approval and institutional permission have been obtained.

Registered date

2026

Year

11

Month

07

Day

Last modified on

2026

Year

11

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072735