UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062633 |
|---|---|
| Receipt number | R000071694 |
| Scientific Title | Evaluation of the usefulness of a hand model as an educational tool for the tricuspid valve: a single-center prospective randomized controlled trial |
| Date of disclosure of the study information | 2026/08/20 |
| Last modified on | 2026/08/20 12:22:57 |
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Basic information
Public title
A study to evaluate the usefulness of a hand model for education on tricuspid valve anatomy
Acronym
HAND-TV study
Scientific Title
Evaluation of the usefulness of a hand model as an educational tool for the tricuspid valve: a single-center prospective randomized controlled trial
Scientific Title:Acronym
HAND-TV trial
Region
| Japan |
Condition
Condition
Knowledge of cardiac anatomy centered on the tricuspid valve (participants are physicians and cardiac sonographers working at the study institution; patients with a specific disease are not enrolled)
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate, in a randomized controlled manner, the usefulness of a newly developed hand model as an educational tool for understanding cardiac anatomy centered on the tricuspid valve, in comparison with conventional education using anatomical illustrations alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Score of the hand-drawn sketch of cardiac anatomy including the tricuspid valve at 2 weeks after the educational intervention, graded by two blinded echocardiography specialists using a predefined scoring sheet, compared between the hand model (HM) group and the control (C) group.
Key secondary outcomes
1) Effect of hand model education provided to the control group after the 2-week assessment (score at 3 months). 2) Scores in both groups at baseline (before education), immediately after education, and at 3 months. 3) Differences in the effect of the hand model according to years of experience and professional category.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Hand model (HM) group: After enrollment and before any education, participants draw a sketch of cardiac structures including the tricuspid valve within about 2 minutes (baseline). They then receive approximately 5 minutes of education using an anatomical illustration plus the hand model. Participants draw the same sketch again within about 2 minutes, without access to any materials, immediately after the education, at 2 weeks, and at 3 months.
Interventions/Control_2
Control (C) group: After enrollment and before any education, participants draw a sketch of cardiac structures including the tricuspid valve within about 2 minutes (baseline). They then receive approximately 5 minutes of education using the anatomical illustration only. They draw the sketch again immediately after the education and at 2 weeks, without access to any materials. After the 2-week assessment, they receive approximately 5 minutes of education using the hand model, and draw the sketch again at 3 months.
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
Physicians working at the study institution (junior residents, internal medicine, cardiovascular surgery, and anesthesiology) and cardiac sonographers of the institution, who have provided written informed consent.
Key exclusion criteria
Participants for whom sufficient information for analysis cannot be obtained, and those judged inappropriate for the study by the investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Arakawa |
Organization
Teikyo University School of Medicine
Division name
Department of Internal Medicine, Division of Cardiology
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL
03-3964-1211
aramasa.masataka.pv@teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Arakawa |
Organization
Teikyo University School of Medicine
Division name
Department of Internal Medicine, Division of Cardiology
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL
03-3964-1211
Homepage URL
aramasa.masataka.pv@teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Masataka Arakawa
Funding Source
Organization
Teikyo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Medical Research, Teikyo University
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
Tel
03-3964-1211
aramasa.masataka.pv@teikyo-u.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
帝京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 20 | 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
No individual participant data (IPD) will be shared.
IPD sharing Plan description
This is a single-center educational intervention study, and there is currently no plan to share individual participant data.
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a single-center randomized controlled trial approved by the Ethics Committee for Medical Research of Teikyo University (approval number: Teirin 25-047). Participants are physicians and cardiac sonographers working at the institution; patients are not enrolled. For the hand model, see: Kataoka A, Arakawa M, Ota T. JACC Case Rep. 2025 Mar 5;30(5):103027.
Management information
Registered date
| 2026 | Year | 08 | Month | 20 | Day |
Last modified on
| 2026 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071694
