UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048648 |
|---|---|
| Receipt number | R000055430 |
| Scientific Title | Validation and reliability of a Japanese version of the Food Allergy Quality of Life Questionnaire - Teenager Form and Adult Form |
| Date of disclosure of the study information | 2022/08/11 |
| Last modified on | 2023/09/06 13:04:03 |
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Basic information
Public title
Validation and reliability of a Japanese version of the Food Allergy Quality of Life Questionnaire - Teenager Form and Adult Form
Acronym
Validation of a Japanese version of the FAQLQ - TF and AF
Scientific Title
Validation and reliability of a Japanese version of the Food Allergy Quality of Life Questionnaire - Teenager Form and Adult Form
Scientific Title:Acronym
Validation of a Japanese version of the FAQLQ - TF and AF
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will develop a Japanese version of the Food Allergy Quality of Life Questionnaire-Teenager Form (FAQLQ-TF) and Adult Form (FAQLQ-AF), and validate it.
Basic objectives2
Others
Basic objectives -Others
We will evaluate risk factors that reduce the quality of life of patients with food allergies.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the validity of the Japanese version of the FAQLQ-TF and -FAQLQ-AF newly developed.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patients diagnosed by a physician as having a food allergy
2. FAQLQ-TF: 13 years old and over but under 18 years old
FAQLQ-AF: 18 years and older
Key exclusion criteria
1. Patients who have difficulty answering the questionnaire by themselves
2. Patients who have difficulty communicating in Japanese
3. Patients who cannot obtain consent for the research from themselves or their guardians
4. Other patients whom the principal investigator deems inappropriate as research subjects.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yanagida |
Organization
National Hospital Organization Sagamihara Hospital
Division name
JAPAN 252-0392
Zip code
252-0392
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
TEL
+81-42-742-8311
yana@foodallergy.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Fusayasu |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
TEL
+81-42-742-8311
Homepage URL
nen19842000@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant.
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
National Hospital Organization Sagamihara National Hospital
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa, JAPAN 252-0392
Tel
042-742-8311
222-rinri@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research and survey items
1. The following clinical information will be obtained on the research subjects by means of a questionnaire.
1.1 Japanese version of the FAQLQ-TF or the FAQLQ-AF
1.2 FAIM Japanese version
1.3 EQ-5D-5L
1.4 Food Allergy Questionnaire for Patients
1.5 Clinical findings (last education, working status, schooling status, marital status, and details of food allergy)
2. The following clinical information on the research subjects will be obtained from the medical records.
2.1 Clinical findings (details of food allergy)
2.2 Blood findings
Management information
Registered date
| 2022 | Year | 08 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055430
| Research Plan | |
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