UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058015 |
|---|---|
| Receipt number | R000066275 |
| Scientific Title | The Influence of Case-Based Learning on Clinical Reasoning of New Graduate Occupational Therapists: Waitlist Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/26 19:37:04 |
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Basic information
Public title
The Influence of Case-Based Learning on Clinical Reasoning of New Graduate Occupational Therapists: Waitlist Randomized Controlled Trial
Acronym
The Influence of Case-Based Learning on Clinical Reasoning: RCT
Scientific Title
The Influence of Case-Based Learning on Clinical Reasoning of New Graduate Occupational Therapists: Waitlist Randomized Controlled Trial
Scientific Title:Acronym
The Influence of Case-Based Learning on Clinical Reasoning: Waitlist RCT
Region
| Japan |
Condition
Condition
Occupational therapists (Healthy)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the influence of experiential learning through case-based learning of clinical reasoning in new occupational therapists through a multi-center waitlist randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-assessment scale of clinical reasoning in occupational therapy (SA-CROT) and educator rating of SA-CROT
Self-rating and educator rating of the global rating scale of change (GRC)
Key secondary outcomes
Japanese version of the Occupational Based Practice Measure (OBPM-J)
Behavioral Indicators of Evidence-Based Practice
Visual Analog Scale method for self-efficacy in clinical practice
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Case-based learning program. The educator guides and consults the learner through practical experience, and teaches the learner how to gather information (such as how to ask questions of seniors and how to research literature) to access prior knowledge related to the case. The educator also organizes the learner's thoughts and reinforces their perspective. The educator discusses the case with the learner and provides feedback. Face-to-face, at the hospital facility. Total 960 minutes (60 minutes/session x 3 days x 8 weeks).
Interventions/Control_2
A traditional education program based on preceptorship. Educators guide and consult with learners through on-site practice, and provide instruction and advice on occupational therapy assessment and intervention methods to improve their practical skills as occupational therapists. Educators also explain prerequisite knowledge for the content of instruction and introduce literature (guidelines, research papers, etc.) as necessary. Face-to-face, within a hospital facility. Total of 960 minutes (60 minutes/session x 3 days x 8 weeks).
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
Those are new graduates (with less than 1 year of experience) in the year of implementation (including those with work experience)
Those are employed full-time
Those aged 20 to 60
Those have given written consent to participate in this study
Key exclusion criteria
Those on maternity leave
Those working reduced hours
Those who are unable to participate in the program for more than a week.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Maruyama |
Organization
Shonan Keiku Hospital
Division name
Department of Rehabilitation
Zip code
2520816
Address
Endo 4360, Fujisawa city, Kanagawa pref.
TEL
0466480050
s-maruyama@keiiku.gr.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Maruyama |
Organization
Shonan Keiiku Hospital
Division name
Department of Rehabilitation
Zip code
2520816
Address
Endo 4360, Fujisawa city, Kanagawa pref.
TEL
0466480050
Homepage URL
s-maruyama@keiiku.gr.jp
Sponsor or person
Institute
Shonan Keiiku 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
Shonan Keiiku Hospital
Address
Endo 4360, Fujisawa city, Kanagawa pref.
Tel
0466480050
s-maruyama@keiiku.gr.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
神奈川県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | 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
| 2025 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | 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
Management information
Registered date
| 2025 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066275
