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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029414
Receipt No. R000033611
Scientific Title Keio COPD Better life Research
Date of disclosure of the study information 2017/10/06
Last modified on 2017/11/24

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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
Middle name
Last name Tomoko Betsuyaku
Organization Keio University School of Medicine
Division name Division of Pulmonary Medicine, Department of Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL 03-5363-3406
Email tbetsuyaku@z5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shotaro Chubachi
Organization Keio University School of Medicine
Division name Division of Pulmonary Medicine, Department of Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL 03-5363-3406
Homepage URL
Email bachibachi472000@z6.keio.jp

Sponsor
Institute Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Anticipated trial start date
2017 Year 10 Month 10 Day
Last follow-up date
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
2017 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033611

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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