UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061343 |
|---|---|
| Receipt number | R000070120 |
| Scientific Title | DrHyQ6 Reliability and Instrument Validity in the Japanese Version |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/21 18:53:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
DrHyQ6 Reliability and Instrument Validity in the Japanese Version
Acronym
DRIV Study
Scientific Title
DrHyQ6 Reliability and Instrument Validity in the Japanese Version
Scientific Title:Acronym
DRIV Study
Region
| Japan |
Condition
Condition
Drug hypersensitivity reactions
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the reliability and validity of the Japanese version of the DrHyQ6 (Drug Hypersensitivity Quality of Life Questionnaire-6), a health-related quality of life (HRQoL) assessment tool specific to drug hypersensitivity reactions (DHR), through a prospective observational study.
Basic objectives2
Others
Basic objectives -Others
Reliability and validity of the Japanese version
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Internal consistency: The overall scale consistency will be assessed using Cronbach's alpha and McDonald's omega.
Test-retest reliability: The Intraclass Correlation Coefficient (ICC) will be calculated (1-2 week interval; adult subsample, n=40).
Construct validity: Confirmatory factor analysis (CFA) will be used to evaluate the goodness of fit of a one-factor, six-item model (e.g., CFI, TLI, RMSEA).
Convergent/discriminant validity: Correlation coefficients (Pearson or Spearman) with SF-36 subscales (particularly the mental health and social functioning domains) will be calculated to examine conceptual relationships.
Key secondary outcomes
Known-groups validity: DrHyQ6 scores will be compared between patients with a history of a single culprit drug vs. multiple culprit drugs, and between those with a history of severe reactions vs. non-severe reactions; additionally, where clinical follow-up data are available, confirmed cases vs. excluded cases will be compared.
Between-group differences in DrHyQ6 scores will be analyzed using the t-test or Mann-Whitney U test.
Pediatric cases (exploratory analysis): Descriptive statistics and internal consistency will be evaluated, along with a preliminary assessment of PedsQL 4.0 scores.
Base
Study type
Observational
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
| 2 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study is intended for patients who meet all of the following criteria:
(1) Patients with suspected drug hypersensitivity reactions (DHR) or a documented history of such reactions in their medical records
(2) Patients aged 2 years or older
(3) Patients who have provided written informed consent
(4) Patients or their guardians who are capable of understanding and responding to a questionnaire in Japanese
(5) Participants in the retest reliability evaluation (adult subgroup)
Key exclusion criteria
Patients who meet any of the following criteria will not be included in this study.
(1) Individuals deemed unable to complete the questionnaire reliably
(2) Individuals in an acute medical emergency
(3) Individuals exhibiting acute severe psychiatric symptoms
(4) Any other individuals deemed ineligible by the principal investigator or attending physician from a medical or ethical standpoint
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mizuho |
| Middle name | |
| Last name | Nagao |
Organization
NHO Mie National Hospital
Division name
Department of Clinical Research
Zip code
5140125
Address
357, Ozato-kubota-cho, Tsu, Mie, Japan
TEL
059-232-2531
mieclinicalresearch@gmail.com
Public contact
Name of contact person
| 1st name | Marei |
| Middle name | |
| Last name | Omori |
Organization
NHO Mie National Hospital
Division name
Department of Allergy
Zip code
5140125
Address
357, Ozato-kubota-cho, Tsu, Mie, Japan
TEL
059-232-2531
Homepage URL
mieclinicalresearch@gmail.com
Sponsor or person
Institute
Department of Clinical Research, NHO Mie National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
National Hospital Organization
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo, Japan
Tel
03-5712-5050
700-info@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
| 2026 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For all patients with drug allergies (including suspected cases) who provided informed consent, the Japanese version of the DrHyQ6 will be administered, along with the SF-36 for adults and the PedsQL for children.
Based on the collected data, including patient demographics, the reliability and validity of the Japanese version of the DrHyQ6 will be verified through a prospective observational study.
Management information
Registered date
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070120
