Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061044) titled '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' on April 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Ehime Prefectural Central Hospital
Condition:
Condition - Ulcerative colitis
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 16
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 Size - 200
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069814
Disclaimer: Curated by HT Syndication.