UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050411 |
|---|---|
| Receipt number | R000057395 |
| Scientific Title | Online survey of patients with progressive fibrosing interstitial lung disease (PF-ILD) in Japan - A study of physician and patient experiences and perceptions of the course of treatment from initial symptom onset to the time of the survey - |
| Date of disclosure of the study information | 2023/02/22 |
| Last modified on | 2023/08/30 20:10:56 |
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Basic information
Public title
Online survey of patients with progressive fibrosing interstitial lung disease (PF-ILD) in Japan
- A study of physician and patient experiences and perceptions of the course of treatment from initial symptom onset to the time of the survey -
Acronym
Online survey of patients with progressive fibrosing interstitial lung disease (PF-ILD) in Japan
- A study of physician and patient experiences and perceptions of the course of treatment from initial symptom onset to the time of the survey -
Scientific Title
Online survey of patients with progressive fibrosing interstitial lung disease (PF-ILD) in Japan
- A study of physician and patient experiences and perceptions of the course of treatment from initial symptom onset to the time of the survey -
Scientific Title:Acronym
Online survey of patients with progressive fibrosing interstitial lung disease (PF-ILD) in Japan
Region
| Japan |
Condition
Condition
Progressive fibrosing interstitial lung disease
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine factors that hinder early diagnosis and early intervention by ascertaining actual conditions such as disease awareness and time to start treatment through a questionnaire survey of patients with progressive fibrosing interstitial lung disease (PF-ILD) and physicians with sufficient experience in treating patients with PF-ILD
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Information on patient backgrounds, disease, treatment experience and awareness of patients with PF-ILD obtained from the physician questionnaire survey
2) Information on patient backgrounds, disease, treatment experience and perceptions of patients with PF-ILD obtained from the patient questionnaire survey
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Inclusion criteria for physicians>
1) Physicians who are engaged in medical treatment at medical institutions in Japan
2) Physicians with sufficient experience in treating patients with PF-ILD
3) Physicians who have agreed with the objective of the study and provided informed consent of their own free will by themselves electromagnetically on the website for answering the physician questionnaire and requesting questionnaires to multiple patients
<Inclusion criteria for patients>
1) Patients aged 18 years or older (regardless of gender)
2) Patients with a confirmed diagnosis of PF-ILD and continuing treatment (regardless of whether the patient is an outpatient or inpatient)
3) Patients who have been informed by their physician that they have PF-ILD
4) Patients who can provide information before and after the start of treatment for PF-ILD (within approximately 12 months after the start of treatment for PF-ILD)
5) Patients who can understand Japanese
6) Patients who can access the website and complete the questionnaire
7) Patients who have carefully read the explanatory document regarding this study and have given informed consent of their own free will by themselves electromagnetically on the website to participate in this study
Key exclusion criteria
<Exclusion criteria for physicians>
Not applicable
<Exclusion criteria for patients>
1) Patients with a confirmed diagnosis of IPF
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tomoo |
| Middle name | |
| Last name | Okamura |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Specialty Care Medicine, Medicine Division
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
03-6417-2444
tomoo.okamura@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Tomoo |
| Middle name | |
| Last name | Okamura |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Specialty Care Medicine, Medicine Division
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
03-6417-2444
Homepage URL
tomoo.okamura@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takahashi Clinic Ethics Committee
Address
Medicalhat 1F , 5-1-31 ,kitamachi ,iwaya, nada-ku, kobe-shi, Hyogo, Japan
Tel
078-882-6432
kishimoto.satoshi@neues.co.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 | 02 | Month | 22 | 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
141
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
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 19 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 19 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 24 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 08 | Day |
Other
Other related information
This study will survey to determine the disease awareness and perception of PF-ILD and the time to initiate treatment on physicians and patients via the Web.
Management information
Registered date
| 2023 | Year | 02 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057395
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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