UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029414 |
|---|---|
| Receipt number | R000033611 |
| Scientific Title | Keio COPD Better life Research |
| Date of disclosure of the study information | 2017/10/06 |
| Last modified on | 2022/05/06 10:26:00 |
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Basic information
Public title
Keio COPD Better life Research
Acronym
K-CBR
Scientific Title
Keio COPD Better life Research
Scientific Title:Acronym
K-CBR
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By examining the knowledge of COPD, drug compliance, satisfaction level in Japanese COPD patients, we determine factors that influences on these outcomes using mainly the questionnaires.
Basic objectives2
Others
Basic objectives -Others
By examining the knowledge of COPD, drug compliance, satisfaction level in COPD patients, we investigate their effects on QOL, the number of hospitalizations and prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL
Key secondary outcomes
knowledge of COPD, drug compliance, satisfaction level in COPD patients,number of hospitalizations and prognosis
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
definite COPD
Key exclusion criteria
consent for this research is not obtained
Target sample size
7100
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Fukunaga |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL
03-5363-3406
kfukunaga@keio.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Chubachi |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL
03-5363-3406
Homepage URL
bachibachi472000@z6.keio.jp
Sponsor or person
Institute
Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University IRB
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.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
①慶應義塾大学病院（東京都）、②北里大学北里研究所病院（東京都）、③永寿総合病院（東京都）、④東京都済生会中央病院（東京都）、⑤東京歯科大学市川総合病院（千葉県）、⑥済生会宇都宮病院（栃木県）、⑦国立病院機構 東京医療センター（東京都）、⑧佐野厚生総合病院（栃木県）、⑨埼玉メディカルセンター（埼玉県）、⑩日野市立病院（東京都）、⑪川崎市立川崎病院（神奈川県）、⑫日本鋼管病院（神奈川県）、⑬川崎市立井田病院（神奈川県）、⑭さいたま市立病院（埼玉県）、⑮けいゆう病院（神奈川県）、⑯国家公務員共済連合会 立川病院（東京都）
①Keio University School of Medicine、②Kitasato University Kitasato Institute Hospital、③Eiju General Hospital、④Tokyo Saiseikai Central Hospital、⑤Tokyo Dental College Ichikawa General Hospital、⑥Saiseikai Utsunomiya Hospital、⑦National Hospital Organization Tokyo Medical Center、⑧Sano Kousei General Hospital、⑨Saitama Medical Center、⑩Hino Municipal Hospital、⑪Kawasaki Municipal Hospital、⑫Nihon Koukan Hospital、⑬Kawasaki Municipal Ida Hospital、⑭Saitama Municipal Hospital、⑮Keiyu Hospital、⑯Tachikawa Hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033611
| 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 |
