UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050195 |
|---|---|
| Receipt number | R000056903 |
| Scientific Title | A questionnaire survey of physicians and patients on onychomycosis treatment |
| Date of disclosure of the study information | 2023/01/31 |
| Last modified on | 2023/01/31 13:51:33 |
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Basic information
Public title
A questionnaire survey of physicians and patients
on onychomycosis treatment
Acronym
A questionnaire survey of physicians and patients
on onychomycosis treatment
Scientific Title
A questionnaire survey of physicians and patients
on onychomycosis treatment
Scientific Title:Acronym
A questionnaire survey of physicians and patients
on onychomycosis treatment
Region
| Japan |
Condition
Condition
Onychomycosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the current issues in the treatment of onychomycosis, and then, from the perspective of behavioral economics, to examine approaches such as patient guidance methods to solve these issues.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examine patient guidance methods and other approaches to solve the problem of onychomycosis treatment from the perspective of behavioral economics.
Key secondary outcomes
Visualization of the following issues in onychomycosis treatment.
･Issues in setting treatment goals
･Issues in Physician-Patient communication
･Perception gaps between patients and physicians in shared decision making([SDM-Q-9])
･Issues in treatment selection
･Challenges in continuing treatment
･Satisfaction with treatment, etc.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Patient Survey]
1. Patients 20 years of age or older who were diagnosed with onychomycosis and experienced onychomycosis treatment between January 1, 2019 and June 30, 2022.
2. Patients prescribed drugs indicated for the treatment of onychomycosis on or after 2019.
[Physician Survey]
1. Dermatologists who provide onychomycosis treatment.
Key exclusion criteria
[Patient survey]
Patients who do not meet the inclusion criteria
[Doctors survey]
Doctors who do not meet the inclusion criteria
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | YUICHIRO |
| Middle name | |
| Last name | TSUNEMI |
Organization
Saitama Medical University
Division name
Dermatology
Zip code
350-0495
Address
38 Morohongo, Moroyamamachi, Irumagun, Saitama, Japan
TEL
049-276-1111
tsunemi.yuichiro@gmail.com
Public contact
Name of contact person
| 1st name | ETSUKO |
| Middle name | |
| Last name | IWASHITA |
Organization
QLife Inc.
Division name
Patient Recruitment Dept
Zip code
105-0001
Address
Toranomon33Mori-Bld.10F Toranomon,Minato-Ku,Tokyo,Japan
TEL
03-6860-5020
Homepage URL
e-iwashita@qlife.co.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Eisai Co, Ltd.
IRB Contact (For public release)
Organization
Noguchi Dermatology Clinic Ethics Committee
Address
964-1, Uejima, Kashima-machi, Kamimashiki-gun, Kumamoto, 861-3106
Tel
096-237-4112
derma@nogcli.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
| 2023 | Year | 01 | Month | 31 | 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
| 2023 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will collect information through a questionnaire survey of physicians and patients.
The information to be collected is indicated in the "Assessment" section.
A separate receipt survey will be conducted on the continuation of treatment with onychomycotic medications.
[Receipt Survey]
The receipt survey will extract and compile receipt data (NMD:National Medical Data) from medical institutions contracted with the International Research Institute of Medical Strategy, Ltd.
Survey period:January 2021 - December 2022
Subjects : Patients prescribed drugs indicated for onychomycosis from January 2021 to December 2021
(except for patients who were prescribed a treatment indicated for onychomycosis from January 2020 to December 2020)
Management information
Registered date
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056903
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
