UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050489 |
|---|---|
| Receipt number | R000057513 |
| Scientific Title | Development and learning environment evaluation of hybrid learning program in patient encounter among medical students: open-label, randomized, parallel-group study |
| Date of disclosure of the study information | 2023/03/06 |
| Last modified on | 2025/03/11 16:15:32 |
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Basic information
Public title
Development and learning environment evaluation of hybrid learning program in patient encounter among medical students
Acronym
Hybrid learning program study
Scientific Title
Development and learning environment evaluation of hybrid learning program in patient encounter among medical students: open-label, randomized, parallel-group study
Scientific Title:Acronym
Hybrid learning program study
Region
| Japan |
Condition
Condition
patients in primary care setting
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the validity of the educational environment of novel hybrid learning program in medical interviews by comparing traditional face-to-face learning
Basic objectives2
Others
Basic objectives -Others
validity
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference of total score of 24 questions associated with students' perception of learning and atmosphere from Dundee Ready Educational Environment Measure (DREEM) between face-toface group and hybrid learning group
Key secondary outcomes
1 The difference of scores of each category (students' perception of learning and atmosphere) from DREEM between face-to-face group and hybrid learning group
2 The difference of changes in self-assessment of students' clinical competence before and after the lerning program between face-to-face group and hybrid learning group
3 The difference of changes in scores of pretest and posttest between face-to-face group and hybrid learning group
4 Descriptions of any comments in the questionnaire after the learning program
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Hybrid learning group: Hybrid learning group undergoes 5-hour hybrid learning program (face-to-face and online) in medical interview including simulations with mock patients in three weeks. Simulations consist of three sessions; first and second sessions are online, and third session is face-to-face. An attending doctor, who also performs as a mock patient, and medical students are in the same classroom during a face-to-face session. We use some video conferencing platforms for online sessions, and both an attending doctor and medical students join it from anywhere on campus via a wireless LAN.Before and after the learning program, participants take the objective structured clinical examination of face-to-face medical interview with mock patients and finish self-assessment of their clinical competence.They also response a questionnaire about the learning program.
Interventions/Control_2
Face-to-face group: Face-to-face group undergoes 5-hour face-to-face learning program in medical interview including simulations with mock patients in three weeks. Simulations consist of three face-to-face sessions. An attending doctor, who also performs as a mock patient, and medical students are in the same classroom during sessions. Before and after the learning program, participants take the objective structured clinical examination of face-to-face medical interview with mock patients and finish self-assessment of their clinical competence.They also response a questionnaire about the learning program.
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
Fourth-, fifth-, and sixth-year students with written informed consent at Dokkyo Medical University
Key exclusion criteria
Medical students who have previously rotated department of diagnostic and generalist medicine and experienced hybrid lerning program in medical interviews in the clinical clerkship
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Yokose |
Organization
Dokkyo Medical University
Division name
Department of Diagnostic and Generalist Medicine
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-86-1111
myokose@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Yokose |
Organization
Dokkyo Medical University
Division name
Department of Diagnostic and Generalist Medicine
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-87-2498
Homepage URL
myokose@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Yokose Masashi
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Committee, Dokkyo Medical University
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi
Tel
0282-87-2474
kenkyu@dokkyomed.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
| 2023 | Year | 03 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2023 | 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
Management information
Registered date
| 2023 | Year | 03 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057513
