UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053895 |
|---|---|
| Receipt number | R000061522 |
| Scientific Title | Web-based Survey Study on Physician Awareness of Acquired Hemophilia A (AHA) in Japan |
| Date of disclosure of the study information | 2024/03/19 |
| Last modified on | 2024/03/19 09:45:09 |
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Basic information
Public title
Web-based Survey Study on Physician Awareness of Acquired Hemophilia A (AHA) in Japan
Acronym
Web-based Survey Study on Physician Awareness of Acquired Hemophilia A (AHA) in Japan
Scientific Title
Web-based Survey Study on Physician Awareness of Acquired Hemophilia A (AHA) in Japan
Scientific Title:Acronym
Web-based Survey Study on Physician Awareness of Acquired Hemophilia A (AHA) in Japan
Region
| Japan |
Condition
Condition
Acquired Hemophilia A
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
-To determine levels of Acquired Hemophilia A (AHA) awareness among Japanese physicians who are non-hematologists from various specialties
-To understand what kind of diseases are predicted by non-hematologists when they see their patients with spontaneous bleedings
Basic objectives2
Others
Basic objectives -Others
Web-based Survey
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Disease awareness level of AHA as assessed by the following items
-Rate of physicians knowledge for AHA as assessed by recognition of AHA's presence, examination experiences based on the symptoms of the disease and number of patients based on the demographic data (physicians; department they belong to, facility type they are working at, and academic affiliation they belong to)
Key secondary outcomes
-Rate of suspecting AHA when physicians encounter a patient with typical bleeding symptoms of AHA
-Sources of AHA information, interest, experience of examination, diagnosis and treatment and referral to other clinical departments
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
Physicians who belong to the following clinical departments
Dermatology, emergency medicine, orthopedics, obstetrics & gynecology, oncology, general medicine, gastroenterology, urology, gastroenterology surgery, respiratory surgery, neurosurgery, rheumatology & collagen medicine, geriatrics, pediatrics, general internal medicine
Key exclusion criteria
1. Physicians with less than two years of clinical experience at giving their consent (excluding residency)
2. Physicians working in facilities other than clinics, university hospitals, general hospitals, national and public hospitals at giving their consent
3. Physicians who are not treating either outpatients or inpatients at giving their consent
4. Physicians who require regal representatives
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Miyaguchi |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo
TEL
070-4921-7966
yasuo.miyaguchi1@takeda.com
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Go |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo
TEL
090-1872-0300
Homepage URL
madoka.go@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Physicians Association Institutional Review Board
Address
Tokyo Medical Association Building 4F, 2-5, Kanda-Surugadai, Chiyoda, Tokyo
Tel
03-3259-6177
irb@nichirinnai.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
| 2024 | Year | 03 | Month | 19 | 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
| 2024 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 08 | Month | 31 | Day |
Other
Other related information
This study is a prospective, cross-sectional, observational study, and a web survey for physicians without speciality in hematology to collect information regarding the disease awareness of AHA. It will be conducted for two weeks. The data obtained in this survey is anonymized and individuals cannot be identified.
Management information
Registered date
| 2024 | Year | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061522
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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