UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061760 |
|---|---|
| Receipt number | R000070676 |
| Scientific Title | Assessment and Challenges of Communication Skills in General Practice Residents: Analysis of Medical Interviews Using the Roter Interaction Analysis System (RIAS) |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/01 13:30:09 |
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Basic information
Public title
Assessment and Challenges of Communication Skills in General Practice Residents: Analysis of Medical Interviews Using the Roter Interaction Analysis System (RIAS)
Acronym
Communication Assessment of General Practice Residents
Scientific Title
Assessment and Challenges of Communication Skills in General Practice Residents: Analysis of Medical Interviews Using the Roter Interaction Analysis System (RIAS)
Scientific Title:Acronym
Communication Assessment of General Practice Residents
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the communication skills of general practice residents.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conversation Category Ratio, Patient-Centeredness Score
Key secondary outcomes
The Consultation and Relational Empathy Measure (CARE measure), Patient Centered Observation Form (PCOF)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 24 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All residents enrolled in the Tsukuba Family Medicine and Hospital Generalist Training Program.
Key exclusion criteria
Not applicable
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kimura |
Organization
University of Tsukuba
Division name
Department of Family Medicine, General Practice and Community Health, Faculty of Medicine
Zip code
305-8575
Address
1- 1- 1 Tenno- dai, Tsukuba, Ibaraki Japan.
TEL
029-853-3189
noriyuki-kmeb@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kimura |
Organization
University of Tsukuba
Division name
Department of Family Medicine, General Practice and Community Health, Faculty of Medicine
Zip code
305-8575
Address
1- 1- 1 Tenno- dai, Tsukuba, Ibaraki Japan
TEL
029-853-3189
Homepage URL
noriyuki-kmeb@md.tsukuba.ac.jp
Sponsor or person
Institute
University of tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Primary Care Association
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
University of Tsukuba
Address
2- 1- 1 Tenno- dai, Tsukuba, Ibaraki Japan
Tel
0298533914
t-credo.adm@un.tsukuba.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
| 2026 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Phase 1:Clinical Skill Assessment (CSA) sessions, conducted annually for general practice residents, will be video-recorded and analyzed using the Roter Interaction Analysis System (RIAS). Analyses performed by an artificial intelligence (AI) system trained on the RIAS coding protocol will be compared with those conducted by human researchers. Based on these comparisons, a methodology for AI-assisted RIAS analysis will be developed and validated.
Phase 2:Outpatient consultations conducted by general practice residents will be video-recorded every 3 to 6 months. Audio data extracted from these recordings will be analyzed using the AI-based RIAS analysis system established in Phase 1. Patients will be asked to complete the CARE Measure questionnaire, while supervising physicians will evaluate residents using the Patient-Centered Observation Form (PCOF). These data will be integrated to examine longitudinal changes in residents' communication skills throughout their training.
Management information
Registered date
| 2026 | Year | 06 | Month | 01 | Day |
Last modified on
| 2026 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070676
