Tokyo, April 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060705) titled 'A study to examine whether AI avatar-based pre-discharge explanations improve patients' understanding and satisfaction' on April 26.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Keio University Hospital
Condition:
Condition - Adult patients with gastrointestinal diseases scheduled for hospital discharge
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to prospectively and quantitatively evaluate the effects of three pre-discharge education methods - traditional face-to-face instruction, conventional video-based education, and AI avatar-based video education - on nursing workflow efficiency, patient understanding, and patient satisfaction. In a subset of participants, electroencephalographic measurements will be conducted using an affective analyzer to objectively assess the acceptability of the AI avatar-based video.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - AI avatar video + face-to-face instruction
Interventions/Control_2 - Conventional video + face-to-face instruction
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 Size - 90
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 01 Day
Anticipated trial start date - 2026 Year 04 Month 27 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069406
Disclaimer: Curated by HT Syndication.