UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062404 |
|---|---|
| Receipt number | R000071033 |
| Scientific Title | Development and Evaluation of a Three-Layer Governance Implementation Strategy to Overcome Workforce Juniorization Risk in Subacute Rehabilitation Organizations: A Multicenter Controlled Interrupted Time Series Analysis with Delayed-Implementation External Replication |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2026/08/11 14:07:33 |
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Basic information
Public title
Development and Evaluation of a Three-Layer Governance Implementation Strategy to Overcome Workforce Juniorization Risk in Subacute Rehabilitation Organizations: A Multicenter Controlled Interrupted Time Series Analysis with Delayed-Implementation External Replication
Acronym
Development and Evaluation of a Three-Layer Governance Implementation Strategy to Overcome Workforce Juniorization Risk in Subacute Rehabilitation Organizations: A Multicenter Controlled Interrupted Time Series Analysis with Delayed-Implementation External Replication
Scientific Title
Development and Evaluation of a Three-Layer Governance Implementation Strategy to Overcome Workforce Juniorization Risk in Subacute Rehabilitation Organizations: A Multicenter Controlled Interrupted Time Series Analysis with Delayed-Implementation External Replication
Scientific Title:Acronym
Development and Evaluation of a Three-Layer Governance Implementation Strategy to Overcome Workforce Juniorization Risk in Subacute Rehabilitation Organizations: A Multicenter Controlled Interrupted Time Series Analysis with Delayed-Implementation External Replication
Region
| Japan |
Condition
Condition
All conditions for which patients may be admitted to the post-acute rehabilitation ward
Classification by specialty
| Neurology | Orthopedics | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To overcome the organizational risks associated with the trend towards younger staff in convalescent rehabilitation wards, we will develop a 'three-tier governance' model that integrates AI-powered movement analysis training (Hard), organizational coordination (Soft), and the fostering of psychological safety (Heart). The aim of this study is to verify, using a multi-centre difference-in-differences (DiD) analysis, the effects of this model on the standardization of therapists' skills, the reduction of staff's physical and mental workload, improvements in ward performance indicators (FIM gain and reduction in length of stay), and the reduction of staff turnover.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ward-level rehabilitation performance index (the performance index linked to convalescent rehabilitation ward payment), assessed as monthly facility-level values. The primary series is calculated uniformly across the entire analysis period (including the baseline period) using the FY2026 revised definition; the series based on the pre-revision definition is used for sensitivity analysis.
Key secondary outcomes
Changes in the experience-year composition of rehabilitation staff
Staff turnover rate (annual retention rate)
Patient level: FIM gain, disease-specific FIM efficiency, length of stay, home discharge rate
Staff physical and psychological measures: low back pain VAS and fatigue VAS before/after transfer assistance, team psychological safety scale, acceptability/appropriateness/feasibility of the implementation
Implementation outcomes: KAFO protocol adherence rate, days to early intervention (onset to orthosis use), orthosis-management incident rate, number of AI-guided feedback sessions
Process measures: monthly exclusion rate and patient case mix (age, disease category, days from onset, admission FIM distribution) at each site
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
[Intervention Group: Hanabatake Hospital]
Duration: Continuous implementation for 12 months starting July 2026.
Content: Introduction of a 'three-tier governance' model.
1. Hard (As needed): Transfer technique feedback using AI video analysis (VP-Ergono) and introduction of KAFO clinical protocols.
2. Soft (Weekly): Integration of clinical reminders into existing weekly brace rounds for organizational coordination.
3. Heart (Weekly): Weekly leader-staff interviews to monitor mental workload and foster psychological safety.
Interventions/Control_2
[Control Group: Sakurajuji Fukuoka Hospital, Sakurajuji Otemon Hospital, and Sakurajuji Shirokane Rehabilitation Hospital] Duration: 12 months. Content: Continuation of conventional education and management systems without implementation of the three-layer governance model (data are extracted as a full control condition). Note: Sakurajuji Shirokane Rehabilitation Hospital will serve as a control site for the initial 12 months (July 2026 to June 2027) and will subsequently adopt the three-layer governance model (planned for July 2027) as a delayed-implementation site, used for external replication by a single-site interrupted time series analysis.
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
The subjects of this study must meet the following criteria:
1. Patient data: All patients admitted to the convalescent rehabilitation wards of the target facilities and billed for rehabilitation fees during the study period.
2. Staff data: All staff members (e.g., physical therapists, occupational therapists, speech-language-hearing therapists) engaged in clinical practice in the rehabilitation departments of the target facilities during the study period.
Key exclusion criteria
The exclusion criteria are as follows:
1. Data with clear missing values in key metrics required for evaluation (e.g., admission and discharge FIM scores, length of stay, staff experience years).
2. Patient data of those who could not complete the convalescent rehabilitation program due to death, acute exacerbation, or transfer to another ward/hospital.
3. Patients or staff members who explicitly opted out of having their data used for research purposes.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Daichi |
| Middle name | |
| Last name | Yoshida |
Organization
Fukuoka Sakurajuji Medical Corporation Hanabatake Hospital / Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)
Division name
Rehabilitation Department
Zip code
830-0038
Address
914 Nishimachi, Kurume City, Fukuoka Prefecture
TEL
09092057660
mugonjikkou@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Yoshida |
Organization
Fukuoka Sakurajuji Medical Corporation Hanabatake Hospital
Division name
Rehabilitation Department
Zip code
830-0038
Address
914 Nishimachi, Kurume City, Fukuoka Prefecture
TEL
09092057660
Homepage URL
mugonjikkou@yahoo.co.jp
Sponsor or person
Institute
Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kwansei Gakuin University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)
Address
5-11 Watanabe-dori 3-chome, Chuo Ward, Fukuoka City
Tel
092-791-1100
mugonjikkou@yahoo.co.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
医療法人福岡桜十字 花畑病院（福岡県）、医療法人福岡桜十字 桜十字福岡病院（福岡県）、医療法人西福岡桜十字 桜十字大手門病院（福岡県）、医療法人社団峰至会 桜十字白金リハビリテーション病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 30 | 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
| 2026 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071033
