UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039144 |
|---|---|
| Receipt number | R000044631 |
| Scientific Title | Development and assessment of general medicine training program ~ exploring study to development using activity theory~ |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2024/01/19 12:40:35 |
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Basic information
Public title
Development and assessment of general medicine training program ~ exploring study to development using activity theory~
Acronym
Development and assessment of general medicine training program
Scientific Title
Development and assessment of general medicine training program ~ exploring study to development using activity theory~
Scientific Title:Acronym
Development and assessment of general medicine training program
Region
| Japan |
Condition
Condition
not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sharing competencies of general medicine training by focus group.
Basic objectives2
Others
Basic objectives -Others
Determine personal training outcomes using activity theory and intruction design.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
1. Attitude as a profession
360 degree assessment using P-MEX(Professionalism Mini Evaluation Exercise)
2. Clinical skills
Assessment using mini-CEX(mini-Clinical Evaluation Exercise)
3. Attainment of competency
Assessment using personal portfolio or significant event analysis.
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
| Behavior,custom |
Interventions/Control_1
Personal training outcomes are determined using activity theory and intruction design.
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
| 20 | years-old | < |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Medical senior resident(over postgraduate year three) belonging to general medicine or internal medicine.
2. Participants who accept research consent.
3. Participants whose age are over twenty.
Key exclusion criteria
1. When a research participant withdraws consent to participate in research
2. When the research representative and the research coordinator determine that there is a disadvantage to the research participants due to continuing the research.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Tokumasu |
Organization
Okayama university hospital
Division name
General Medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, KIta-ku, Okayama-city
TEL
086-235-7342
tokumasu@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Tokumasu |
Organization
Okayama university hospital
Division name
General Medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, KIta-ku, Okayama-city
TEL
086-235-7342
Homepage URL
tokumasu@okayama-u.ac.jp
Sponsor or person
Institute
Okayama university hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Secretariat of Ethics Review Board Okayama university
Address
2-5-1 Shikata-cho, KIta-ku, Okayama-city
Tel
086-235-6938
mae6605@adm.okayama-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As of January 2024, we are planning to incorporate 2-4 residents.
Management information
Registered date
| 2020 | Year | 01 | Month | 14 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044631
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
