UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039144
Receipt No. 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 2021/07/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tokumasu@okayama-u.ac.jp

Sponsor
Institute Okayama university hospital
Institute
Department

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
Email 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
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We have already taken focus groups and semi-structured interviews for four doctors in 2020, and now we are analyzing these qualitative data.
We cannot include new participants in 2021 because of the COVID-19 pandemic.

Management information
Registered date
2020 Year 01 Month 14 Day
Last modified on
2021 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.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


Contact us.