UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of self-management program for patients with chronic obstructive pulmonary disease (COPD); Multi-center randomized control study
Title of the study (Brief title)	Evaluation of self-management program for COPD patients
Region	Japan

Condition
Condition	Chronic Obstructive Pulmonary Disease (COPD)
Classification by specialty	Pneumology Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of "COPD Life", the Japanese version of "Living well with COPD" self-management education program for Japanese COPD patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of emergency visits and hospitalizations Lung information questionnair (LINQ)
Key secondary outcomes	Quality of life (QOL) Dyspnea

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Provide five sessions for three months using the self-management program COPD life
Interventions/Control_2	usual care
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	Formal diagnosis of COPD Current treatment for COPD No serious complications Consent to participate in the study
Key exclusion criteria	Receiving treatment for a malignant tumor Dementia Serious cardiovascular disease, liver disease, kidney disease
Target sample size	100

Research contact person
Name of lead principal investigator	Ritsuko Wakabayashi
Organization	Kanto Gakuin University
Division name	College of Nursing
Address	1-50-1 Mutsuura-higashi Kanazawaku Yokohamashi, Kanagawa
TEL	045-786-5653
Email	ritsukow@kanto-gakuin.ac.jp

Public contact
Name of contact person	Ritsuko Wakabayashi
Organization	Kanto Gakuin University
Division name	College of Nursing
Address	1-50-1 Mutsuura-higashi Kanazawaku Yokohamashi, Kanagawa
TEL	045-786-5653
Homepage URL
Email	ritsukow@kanto-gakuin.ac.jp

Sponsor
Institute	Kanto Gakuin University
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	福井大学医学部附属病院（福井県） 勤医協中央病院（北海道） 東京女子医科大学八千代医療センター（千葉県） 日本医科大学呼吸ケアクリニック（東京都） 大垣市民病院（岐阜県） 前橋赤十字病院（群馬県） 北信総合病院（長野県） 信州大学医学部附属病院　呼吸器センター（長野県） 坂出市立病院（香川県）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 23 Day
Last modified on	2017 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031453