UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061772 |
|---|---|
| Receipt number | R000070689 |
| Scientific Title | Feasibility Assessment of a Multidisciplinary Remote Follow-Up Model for Supporting Patients After Traffic Accidents |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/02 16:48:38 |
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Basic information
Public title
Feasibility Assessment of a Multidisciplinary Remote Follow-Up Model for Supporting Patients After Traffic Accidents
Acronym
Feasibility Assessment of a Multidisciplinary Remote Follow-Up Model for Supporting Patients After Traffic Accidents
Scientific Title
Feasibility Assessment of a Multidisciplinary Remote Follow-Up Model for Supporting Patients After Traffic Accidents
Scientific Title:Acronym
Feasibility Assessment of a Multidisciplinary Remote Follow-Up Model for Supporting Patients After Traffic Accidents
Region
| Japan |
Condition
Condition
Minor injury
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary outcome is the feasibility of a multidisciplinary remote follow-up intervention for patients after traumatic injury. Feasibility will be assessed primarily by the intervention completion rate.
Intervention completion rate: the percentage of participants who complete all scheduled remote follow-up assessments and interventions up to the final evaluation at 3 months post-discharge.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is the feasibility of a multidisciplinary intervention using online assessment forms and telemedicine tools for patients with traffic-related injuries, with the intervention completion rate serving as the key indicator.
Definition: Intervention completion rate: The proportion of patients who completed the scheduled telemedicine follow-up program through the final assessment point (3 months after discharge).
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
Multidisciplinary Intervention Using Online Assessment Forms and Telemedicine Tools
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This program is intended for patients who meet all of the following criteria:
* Patients who were hospitalized at Kobe University Hospital for treatment of injuries sustained in a traffic accident
* Patients who, following a comprehensive assessment of their physical function, nutritional status, mental and psychological condition, and social support at the time of discharge, were determined to be at risk of physical or mental decline or to require daily living support after discharge (e.g., Barthel Index <= 90, at risk of malnutrition)
* Patients for whom multidisciplinary intervention is feasible within 1 month of discharge
* Patients aged >= 18 years
* Patients who, after receiving operational instructions from the research staff, are confirmed to be capable of connecting to a web conferencing system, using audio and video, and engaging in basic communication using a smartphone, tablet, or computer equipped with camera and microphone functions
* Patients with a stable internet connection (Wi-Fi or mobile data)
* Patients who have provided written informed consent of their own free will
Key exclusion criteria
Patients who meet any of the following criteria will be excluded from the study.
Patients deemed unable to provide appropriate responses to study assessment items or to understand the content of the informed consent due to cognitive impairment
Patients deemed unable to participate in web conferencing systems or operate remote assessment devices due to visual impairment, hearing impairment, or upper limb dysfunction
Patients deemed unable to continue participating in the study due to acute exacerbation of a mental illness, risk of self-harm or harm to others, or a state of significant mental instability
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Nakamura |
Organization
Kobe University Hospital
Division name
Emergency Medicine Department
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Prefecture
TEL
078-382-5111
261m914m@stu.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Oshima |
Organization
Kobe University
Division name
Graduate School of Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Prefecture
TEL
09011006892
Homepage URL
10youth.fy@gmail.com
Sponsor or person
Institute
KOBE University
Institute
Department
Personal name
Funding Source
Organization
FY 2025 JA Mutual Aid Traffic Accident Medical Research Grant
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
KOBEuniversity
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Prefecture
Tel
078-382-6699
chiken@med.kobe-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
| 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 | 06 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 06 | Month | 02 | Day |
Last modified on
| 2026 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070689
