UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047132 |
|---|---|
| Receipt number | R000053742 |
| Scientific Title | Validation of a Japanese version of RECAP questionnaire for adult patients with atopic dermatitis and parents of pediatric patients |
| Date of disclosure of the study information | 2022/03/10 |
| Last modified on | 2024/06/10 14:42:00 |
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Basic information
Public title
Validation of a Japanese version of RECAP questionnaire for adult patients with atopic dermatitis and parents of pediatric patients
Acronym
A prospective validation study of the Japanese version of RECAP questionnaire
Scientific Title
Validation of a Japanese version of RECAP questionnaire for adult patients with atopic dermatitis and parents of pediatric patients
Scientific Title:Acronym
A prospective validation study of the Japanese version of RECAP questionnaire
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate a Japanese version of RECAP questionnaire.
Basic objectives2
Others
Basic objectives -Others
Development and validation of the Japanese version of RECAP, a patient-reported outcome assessment for atopic dermatitis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation coefficient between RECAP and each score (EASI, vIGA, ADCT, POEM, IDQoL, CDLQI, DLQI, DFI, NRS)
Key secondary outcomes
Cronbach's alpha coefficient for each RECAP score, Intraclass correlation coefficient between test and retest in patients with no change in EASI and vIGA, Means and 95% confidence intervals of RECAP total scores among subgroups divided by vIGA scores, Means and 95% confidence intervals for differences from adjacent groups divided by vIGA scores, Minimum clinically meaningful change (MCID), Correlation coefficient with TARC and SCCA2, Correlation coefficients between changes in RECAP and changes in each score, and Area under the ROC curve of RECAP and ADCT for a rise in vIGA from 0 or 1 to >2 (relapse)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet the diagnostic criteria for atopic dermatitis and are currently on guideline-directed treatment are eligible.
Key exclusion criteria
Patients on biologic agents or oral JAK inhibitors with a vIGA score of 0 or 1 at the time of enrollment
Patients with serious complications
Patients receiving oral or intravenous immunosuppressive drugs (except cyclosporine and JAK inhibitors) and steroids
If the patient is considered to have difficulty in answering the questionnaire.
When the principal investigator or sub-investigator judges that participation in this study is not appropriate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Itonaga |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
TEL
042-742-8311
sagamihara.ad@gmail.com
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Itonaga |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
TEL
042-742-8311
Homepage URL
sagamihara.ad@gmail.com
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Sagamihara National Hospital
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, Minami-ku, Sagamihara, Kanagawa, Japan, 252-0392
Tel
042-742-8311
sagamihara.ad@gmail.com
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 | 03 | Month | 10 | 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 | 03 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Translation of the RECAP will be performed by a principal investigator and subinvestigators at the National Hospital Organization Sagamihara Hospital. The Japanese version of RECAP will be evaluated together with other eczema assessment instruments at the time of enrollment and 3 months later at the research participating facilities. In addition, patient characteristics (age, gender, complications, allergic disease complications in family ) and blood test results (TARC, SCCA2) will be collected from the medical records at each facility. Based on the collected data, the reliability and validity of the Japanese version of RECAP will be evaluated.
Management information
Registered date
| 2022 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053742
