UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060889 |
|---|---|
| Receipt number | R000069679 |
| Scientific Title | Evaluation of the Effectiveness, Safety, and Acceptability of an AI-Assisted Chat System for Patient Inquiries in a Smartphone Application After Total Hip Arthroplasty |
| Date of disclosure of the study information | 2026/03/10 |
| Last modified on | 2026/03/10 16:24:44 |
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Basic information
Public title
Evaluation of an AI-assisted chat system for patient inquiries after total hip arthroplasty
Acronym
AI Chat Support for THA Patients
Scientific Title
Evaluation of the Effectiveness, Safety, and Acceptability of an AI-Assisted Chat System for Patient Inquiries in a Smartphone Application After Total Hip Arthroplasty
Scientific Title:Acronym
AI-assisted Chat system for patients after THA
Region
| Japan |
Condition
Condition
Patients undergoing total hip arthroplasty (THA)
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness, safety, and acceptability of an AI-assisted chat system integrated into a smartphone application designed to support patients undergoing total hip arthroplasty (THA).
The study will examine whether the AI system can reduce the workload of healthcare professionals by automatically responding to patient inquiries while maintaining medical appropriateness and patient satisfaction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of healthcare professional message responses per patient.
The outcome will be compared before and after the introduction of the AI-assisted chat system.
Key secondary outcomes
- Response time to patient inquiries
- AI response rate
- AI resolution rate (proportion of inquiries resolved by AI without healthcare professional intervention)
- Medical appropriateness of AI responses evaluated by clinicians
- Patient satisfaction with the chat system
- Net Promoter Score (NPS)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who:
- Undergo total hip arthroplasty at the participating institution
- Use the smartphone application for perioperative rehabilitation support
- Provide informed consent for participation in the study
Key exclusion criteria
Patients who:
- Are unable to use a smartphone application
- Decline participation in the study
- Have cognitive impairment that prevents appropriate use of the chat function
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Nakayama |
Organization
Hokusuikai Kinen Hospital
Division name
Department of Rehabilitation
Zip code
310-0035
Address
3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
TEL
029-303-3003
tsutomu_0616@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Nakayama |
Organization
Hokusuikai Kinen Hospital
Division name
Department of Rehabilitation
Zip code
310-0035
Address
3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
TEL
029-303-3003
Homepage URL
tsutomu_0616@yahoo.co.jp
Sponsor or person
Institute
Hokusuikai Kinen Hospital
Institute
Department
Personal name
Tsutomu Nakayama
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
Hokusuikai Kinen Hospital
Address
3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
Tel
029-303-3003
tsutomu_0616@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
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Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients undergoing total hip arthroplasty use a smartphone application from approximately one month before surgery through the postoperative follow up period.
This study analyzes message data generated through the messaging function of the application during this period.
An AI assisted chat function will be introduced in April 2026. Therefore the postoperative follow up period of the study participants includes both the period before AI implementation and the period after AI implementation.
Based on the timing of message exchanges the following periods will be compared.
Control period January 2026 to March 2026 before AI implementation.
AI implementation period April 2026 to June 2026 after AI implementation.
Management information
Registered date
| 2026 | Year | 03 | Month | 10 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069679
