Tokyo, Nov. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059781) titled 'A study on the impact of using a decision-aid tool on patient-centered care in food allergy management' on Nov. 17.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tokyo Metropolitan Children's Medical Center

Condition: Condition - food allergy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to prospectively evaluate how using the Ottawa Personal Decision Guide for Two to provide decision support affects outcomes of shared decision-making among physicians, pediatric patients, and guardians when considering whether to perform a oral food challenge (OFC) in individuals diagnosed with or suspected of food allergy. Outcomes include changes in understanding of medical information, and whether the decision is patient-centered and based on patient values. Based on findings from our survey, we will identify barriers and facilitators to decision-support in current practice of OFC, and use these to inform the development of a new decision aid aimed at improving SDM outcomes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - We will provide decision-support intervention using the Ottawa Personal Decision Guide for Two.

Eligibility: Age-lower limit - 10 years-old

Gender - Male and Female Key inclusion criteria - Individuals diagnosed with or suspected of having a food allergy and for whom a physician is planning OFC, who after being fully informed about the study and fully understanding its contents, have provided voluntary informed consent or consent by a legal representative. Key exclusion criteria - Participants who meet any of the following will be excluded from the study: 1) Lack of sufficient comprehension of the explanation provided in Japanese, 2) Prior participation in this study and completion of a food challenge test during the study period, 3) Determination by the Principal Investigator that the participant is unsuitable for inclusion in the study. Target Size - 70

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 09 Day Date of IRB - 2025 Year 10 Month 09 Day Anticipated trial start date - 2025 Year 11 Month 25 Day Last follow-up date - 2027 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068353

Disclaimer: Curated by HT Syndication.