UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061044 |
|---|---|
| Receipt number | R000069814 |
| Scientific Title | A prospective interventional study evaluating the clinical utility of a choice architecture informed questionnaire (AT-CHOICE) for decision support in selecting advanced therapy in patients with ulcerative colitis |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/24 20:30:33 |
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Basic information
Public title
A prospective interventional study evaluating the clinical utility of a choice architecture informed questionnaire (AT-CHOICE) for decision support in selecting advanced therapy in patients with ulcerative colitis
Acronym
AT-CHOICE study
Scientific Title
A prospective interventional study evaluating the clinical utility of a choice architecture informed questionnaire (AT-CHOICE) for decision support in selecting advanced therapy in patients with ulcerative colitis
Scientific Title:Acronym
AT-CHOICE study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of a choice architecture informed questionnaire (AT-CHOICE) on the quality of shared decision making in patients with ulcerative colitis undergoing advanced therapy selection.
Basic objectives2
Others
Basic objectives -Others
To explore the associations between decision support and decisional conflict, decision regret, and health-related quality of life.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of shared decision making at the time of advanced therapy selection, assessed using the SDM-Q-9
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patients with ulcerative colitis complete a choice architecture informed questionnaire (AT-CHOICE) prior to advanced therapy selection. The questionnaire is administered once, and the responses are shared between the patient and physician during consultation. Treatment selection is then performed based on shared decision making, considering clinical appropriateness.
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with ulcerative colitis who are scheduled to initiate or switch to advanced therapy and who have provided written informed consent for participation.
Key exclusion criteria
Patients who do not provide informed consent for participation.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Kitahata |
Organization
Ehime Prefectural Central Hospital
Division name
Department of Gastroenterology and IBD Center
Zip code
790-0024
Address
83 Kasuga-cho, Matsuyama City, Ehime
TEL
089-947-1111
shogo_kitahata@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Kitahata |
Organization
Ehime Prefectural Central Hospital
Division name
Department of Gastroenterology and IBD Center
Zip code
790-0024
Address
83 Kasuga-cho, Matsuyama City, Ehime
TEL
089-947-1111
Homepage URL
shogo_kitahata@yahoo.co.jp
Sponsor or person
Institute
Ehime Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Ehime Prefectural Central Hospital
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
Ehime Prefectural Central Hospital
Address
83 Kasuga-cho, Matsuyama City, Ehime
Tel
089-947-1111
shogo_kitahata@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
Institutions
Institutions
愛媛県
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2031 | 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 | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069814
