UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048516 |
|---|---|
| Receipt number | R000055282 |
| Scientific Title | Physician Awareness and Understanding of Chronic Inflammatory Demyelinating Polyneuropathy and Multifocal Motor Neuropathy in Japan: A Web-based Study |
| Date of disclosure of the study information | 2022/08/15 |
| Last modified on | 2024/07/05 15:56:46 |
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Basic information
Public title
Physician Awareness and Understanding of Chronic Inflammatory Demyelinating Polyneuropathy and Multifocal Motor Neuropathy in Japan: A Web-based Study
Acronym
Physician Awareness and Understanding of Chronic Inflammatory Demyelinating Polyneuropathy and Multifocal Motor Neuropathy in Japan: A Web-based Study
Scientific Title
Physician Awareness and Understanding of Chronic Inflammatory Demyelinating Polyneuropathy and Multifocal Motor Neuropathy in Japan: A Web-based Study
Scientific Title:Acronym
Physician Awareness and Understanding of Chronic Inflammatory Demyelinating Polyneuropathy and Multifocal Motor Neuropathy in Japan: A Web-based Study
Region
| Japan |
Condition
Condition
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)/ Multifocal Motor Neuropathy (MMN)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
-To determine the levels of awareness of CIDP/MMN among non-specialists (general internist and orthopedist)
-To determine the level of awareness of CIDP/MMN among specialists (neurologists)
Basic objectives2
Others
Basic objectives -Others
Web-based questionnaire survey
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
-To determine the levels of awareness of CIDP/MMN among non-specialists (general internist and orthopedist)
-To determine the level of awareness of CIDP/MMN among specialists (neurologists)
Key secondary outcomes
-To identify factors that lead to misdiagnosis of CIDP/MMN among specialists
-To determine key factors used to support diagnosis and treatment decisions in CIDP/MMN
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Physicians who are members of medical societies for:
-General internal medicine
-Orthopedics
-Neurology
Key exclusion criteria
The following physicians are excluded:
- Have less than 2 years of clinical practice excluding their training periods
- Who are not actively practicing physicians or work in facilities other than clinics, university hospitals, general hospitals, and national and public hospitals
- Who are currently treating no outpatients and inpatients
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Okamatsu |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
080-7761-5574
nobuaki.okamatsu@takeda.com
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Misaki |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
090-1514-8193
Homepage URL
aiko.misaki@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
Non-Profit Organization MINS Research Ethics Committee
Address
5-20-9-401, Mita, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.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 | 08 | Month | 15 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Published
Result
URL related to results and publications
https://bmjopen.bmj.com/content/14/3/e083669https://bmjopen.bmj.com/content/14/3/e083669
Number of participants that the trial has enrolled
360
Results
In a diagnostic assessment using fictitious case, 95.0% of neurologists, 74.2% of orthopedists, and 72.5% of internists suspected CIDP.
Results date posted
| 2024 | Year | 03 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Because it took a long time to accept this manuscript.
Date of the first journal publication of results
| 2024 | Year | 03 | Month | 08 | Day |
Baseline Characteristics
A web-based survey (Nikkei BP Panel) was conducted among 120 physicians each in the fields of neurology, orthopedics, and internal medicine.
Participant flow
The web survey was first accessed by 845 participants, and 831 of them provided the informed consent form for the study and answered the screening questions. 112physicians were excluded due to the inclusion/exclusion criteria. Furthermore, after excluding 68 ones who did not continue with the survey, 55 with discrepancies in age and years of experience in the current specialty, and 236 due to exceeding the planned data, the final 360 physicians (120 neurologists, 120 orthopedists, and 120 general internists) were the final participants for analyses in the present study.
Adverse events
NA
Outcome measures
In response to questions related to the knowledge level of CIDP, most of the neurologists (n = 109, 90.8%) reported that they understand how to treat this disease or understand how to diagnose it. However, 13 (10.8%) of the orthopedists and 16 (13.3%) of the general internists understood the treatment or diagnose of the disease.
In response to questions related to hypothetical case (Questions 1, 5, 9 and 13), percentage of neurologists who highly suspected/suspected the hypothetical case to be CIDP were 94.2% (n = 113), 77.5% (n = 93), 89.2% (n = 107), and 95.0% (n = 114), respectively. However, percentage of orthopedists who highly suspected/suspected the hypothetical case to be CIDP were 55.8% (n = 67), 38.3% (n =46), 66.6% (n = 80), and 73.1% (n = 89), respectively; and percentage of general internists were 71.7% (n = 86), 35.9% (n =43), 65.0% (n = 78), and 72.5% (n =87), respectively.
In response to questions related to collaboration for CIDP (Question 17), more than 70% of orthopedists and general internists who suspected CIDP answered that they consider referring to a neurologist, while about 10% answered that they continue treatment in their own hospital without referral to other departments.
In response to the treatment which were typically administered to patients with CIDP during routine clinical practice, majority of the neurologists (n = 100, 83.3%) selected IVIg, however, most of the non-specialists (orthopedists, n = 81, 67.5%; general internists, n = 66, 55.0%) preferred referring the patients to another department for treatment.
Of the neurologists selected immunoglobulin for maintenance therapy (Q24-2) and made answer for CIDP to Q26 in this study (n = 49), 27 (55.1%) considered between 1 - 3 months of treatment, 7 (14.3%) ones considered within 1 month of treatment as the appropriate CIDP maintenance therapy time. In other words, 34 (69.4%) indicated less than 3 months was the appropriate CIDP maintenance therapy time for CIDP.
Plan to share IPD
NA
IPD sharing Plan description
NA
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Web based survey for physicians
Management information
Registered date
| 2022 | Year | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055282
