Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061772) titled 'Feasibility Assessment of a Multidisciplinary Remote Follow-Up Model for Supporting Patients After Traffic Accidents' on July 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - KOBE University
Condition:
Condition - Minor injury
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Multidisciplinary Intervention Using Online Assessment Forms and Telemedicine Tools
Eligibility:
Age-lower limit - 20
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 = 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 Size - 20
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070689
Disclaimer: Curated by HT Syndication.