UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027456 |
|---|---|
| Receipt number | R000031453 |
| Scientific Title | Evaluation of self-management program for patients with chronic obstructive pulmonary disease (COPD); Multi-center randomized control study |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2017/08/16 14:24:48 |
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Basic information
Public title
Evaluation of self-management program for patients with chronic obstructive pulmonary disease (COPD); Multi-center randomized control study
Acronym
Evaluation of self-management program for COPD patients
Scientific Title
Evaluation of self-management program for patients with chronic obstructive pulmonary disease (COPD); Multi-center randomized control study
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Ritsuko Wakabayashi |
Organization
Kanto Gakuin University
Division name
College of Nursing
Zip code
Address
1-50-1 Mutsuura-higashi Kanazawaku Yokohamashi, Kanagawa
TEL
045-786-5653
ritsukow@kanto-gakuin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ritsuko Wakabayashi |
Organization
Kanto Gakuin University
Division name
College of Nursing
Zip code
Address
1-50-1 Mutsuura-higashi Kanazawaku Yokohamashi, Kanagawa
TEL
045-786-5653
Homepage URL
ritsukow@kanto-gakuin.ac.jp
Sponsor or person
Institute
Kanto Gakuin University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031453
| 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 |
