UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060794 |
|---|---|
| Receipt number | R000069508 |
| Scientific Title | Evaluation of the Effectiveness and Feasibility of ChatGPT-Based Life Support for Patients with Acute Coronary Syndrome After Percutaneous Coronary Intervention |
| Date of disclosure of the study information | 2026/03/02 |
| Last modified on | 2026/03/02 09:48:38 |
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Basic information
Public title
Effectiveness and Feasibility of ChatGPT-Based Support for Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention
Acronym
ChatSupport-ACS Trial
Scientific Title
Evaluation of the Effectiveness and Feasibility of ChatGPT-Based Life Support for Patients with Acute Coronary Syndrome After Percutaneous Coronary Intervention
Scientific Title:Acronym
CHAT-ACS Study
Region
| Japan |
Condition
Condition
Ten patients with ACS who attended their first outpatient visit following PCI
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to use ChatGPT to support patients with ACS after PCI in addressing their post-discharge concerns and to evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
HADS depression subscale score after two weeks of AI-based support
Key secondary outcomes
Quality of life assessed using the WHOQOL-26 (WHO/Tasaki et al.), specifically the item "How would you rate your quality of life?" , as well as system usability and participants' willingness to use the AI-based support again, evaluated two weeks after initiation of AI use.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Using ChatGPT
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ten patients with ACS attending their first outpatient visit after PCI
Key exclusion criteria
Patients who are unable to provide informed responses due to communication difficulties and those who have been diagnosed with depression by a physician at the time of the outpatient visit.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mana |
| Middle name | |
| Last name | DOI |
Organization
Tokyo Healthcare University
Division name
Chiba Faculty of Nursing, Department of Gerontological Nursing & Home Care Nursing
Zip code
2738710
Address
1-1042-2 Kaijincho-nishi, Funabashi, Chiba
TEL
+81-47-495-7751
m-doi@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Mana |
| Middle name | |
| Last name | DOI |
Organization
Tokyo Healthcare University
Division name
Chiba Faculty of Nursing, Department of Gerontological Nursing & Home Care Nursing
Zip code
2738710
Address
1-1042-2 Kaijincho-nishi, Funabashi, Chiba
TEL
+81-47-495-7751
Homepage URL
m-doi@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Mana DOI
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Healthcare University Ethics Committee
Address
4-1-17, Higashi-gotanda, Shinagawa, Tokyo
Tel
+81-03-5421-7656
kenkyu@thcu.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
千葉市立青葉病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 02 | 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 | 02 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2027 | 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 | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069508
