UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060705 |
|---|---|
| Receipt number | R000069406 |
| Scientific Title | Pilot Study on Pre-Discharge Education Using an AI Avatar: Examining the Feasibility of Different Instruction Methods and the Validity of Evaluation Measures |
| Date of disclosure of the study information | 2026/04/26 |
| Last modified on | 2026/06/21 14:56:07 |
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Basic information
Public title
A study to examine whether AI avatar-based pre-discharge explanations improve patients' understanding and satisfaction: pilot study
Acronym
Patient impact of AI avatar-based pre-discharge explanation: pilot study
Scientific Title
Pilot Study on Pre-Discharge Education Using an AI Avatar: Examining the Feasibility of Different Instruction Methods and the Validity of Evaluation Measures
Scientific Title:Acronym
Patient impact of AI avatar-based pre-discharge education: RCT
Region
| Japan |
Condition
Condition
Adult patients with gastrointestinal diseases scheduled for hospital discharge
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This pilot study aims to implement pre-discharge education using conventional videos and AI avatar videos in real clinical settings and examine their feasibility. In addition, the study will assess the validity of subjective evaluation measures by examining response rates, score distributions, and response burden for items such as understanding, satisfaction, and acceptance. For a subset of participants, physiological response data will be collected using a simplified EEG device (Kansei Analyzer) to explore its potential utility as an objective indicator. Furthermore, the study will collect basic data such as means and standard deviations of key outcome measures to obtain parameters necessary for sample size calculation in the subsequent randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Patient understanding at the end of the first educational session
(objective assessment by healthcare providers using a five-item Likert scale, and subjective assessment using a comprehension test)
Key secondary outcomes
- Time required for healthcare providers' explanations (minutes)
- Number of explanations provided by healthcare providers (count)
- Time required until the start of the intervention
- Patient satisfaction (questionnaire adapted from the CSQ-8)
- Need for additional explanations (presence/absence and content)
- Patient understanding at the first post-discharge outpatient visit
(objective assessment by healthcare providers using a five-item Likert scale, and subjective assessment using a comprehension test)
- Electroencephalographic measurements using an affective analyzer (affective values)
- Nurses' perceived workload (three-item short version of the NASA-TLX)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
AI avatar video + face-to-face instruction
Interventions/Control_2
Conventional video + face-to-face instruction
Interventions/Control_3
Face-to-face instruction only
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients in the Department of Gastrointestinal Surgery or Gastroenterology who have a gastrointestinal drain or catheter in place at the time of discharge
- No age restrictions
- Patients who can understand explanations provided in Japanese
- Patients without dementia or severe cognitive impairment based on cognitive function assessment
(For patients aged 75 years or older, the OLD will be administered, and the MMSE will be performed as needed)
- Patients with no prior experience of having a drain or catheter placed
Key exclusion criteria
- Patients who do not have a gastrointestinal drain or catheter in place at the time of discharge
- Patients suspected of having dementia or severe cognitive impairment
- Patients aged 75 years or older who score 4 or more out of 12 items on the OLD, and additionally score 23 or lower on the MMSE
- Patients with visual or hearing impairments that make it difficult to watch videos or understand explanations
- Patients for whom sufficient time for instruction cannot be secured due to reasons such as urgent discharge
- Patients who have previous experience with a drain or catheter and may already understand self-management methods
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | AKI |
| Middle name | |
| Last name | TSUKADA |
Organization
Keio University Hospital
Division name
nursing department
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
sanae.sasaki@adst.keio.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Tanebe |
Organization
Keio University Hospital
Division name
nursing department
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
saori.tanabe@adst.keio.ac.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503Ext.62014
med-rinri-jimu@adst.keio.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 | 04 | Month | 26 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 27 | 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
| 2026 | Year | 02 | Month | 18 | Day |
Last modified on
| 2026 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069406
