UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059781 |
|---|---|
| Receipt number | R000068353 |
| Scientific Title | Evaluation of Patient-Centered Care Using a Decision Aid in Food Allergy Management: Impact and Patient / Physician Satisfaction |
| Date of disclosure of the study information | 2025/11/17 |
| Last modified on | 2025/11/14 14:07:05 |
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Basic information
Public title
A study on the impact of using a decision-aid tool on patient-centered care in food allergy management
Acronym
A study on the impact of using a decision-aid tool on patient-centered care in food allergy management
Scientific Title
Evaluation of Patient-Centered Care Using a Decision Aid in Food Allergy Management: Impact and Patient / Physician Satisfaction
Scientific Title:Acronym
Evaluation of Patient-Centered Care Using a Decision Aid in Food Allergy Management: Impact and Patient / Physician Satisfaction
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of decision-making and decision-making process quality for patient-centered care: using the Ottawa personal decision guide for two in shared decision-making when conducting OFC.
Key secondary outcomes
Search for factors that may influence the quality and satisfaction of shared decision-making by physicians and patients, and factors that might affect SDM using the Ottawa Personal Decision Guide for Two including patient-side factors, disease factors, and physician factors.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We will provide decision-support intervention using the Ottawa Personal Decision Guide for Two.
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
| 10 | years-old | <= |
Age-upper limit
| 16 | 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 sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Morita |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Allergy
Zip code
183-8561
Address
2-8-29 Musashidai Fuchu, Tokyo, Japan
TEL
042-300-5111
kumiko_morita@tmhp.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Morita |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Allergy
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL
042-300-5111
Homepage URL
kumiko_morita@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Kumiko Morita
Funding Source
Organization
Standard Research Grant of Tokyo Metropolitan Children's Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
Tel
042-300-5111
kumiko_morita@tmhp.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
東京都立小児総合医療センター（東京都）、けいゆう病院（神奈川県）、慶應大学病院 （東京都）、国立病院機構栃木医療センター（栃木県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 17 | 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
| 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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068353
