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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020481
Receipt No. R000023655
Scientific Title Self-management education using cosecutive pulse oximetery for outpatients with chronic pulmonary disease
Date of disclosure of the study information 2016/01/07
Last modified on 2019/01/08

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Basic information
Public title Self-management education using cosecutive pulse oximetery for outpatients with chronic pulmonary disease
Acronym Self-management education using cosecutive pulse oximetery for outpatients with chronic pulmonary disease
Scientific Title Self-management education using cosecutive pulse oximetery for outpatients with chronic pulmonary disease
Scientific Title:Acronym Self-management education using cosecutive pulse oximetery for outpatients with chronic pulmonary disease
Region
Japan

Condition
Condition chronic pulmonary disease
Classification by specialty
Medicine in general Pneumology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate self-management education program using cosecutive pulse oximetery for outpatients with chronic pulmonary disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Variation of the oxygen desaturation before and after self-management education program
Key secondary outcomes Variation of dyspnea, ADL, and 6MWT before and after self-management education program

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 self-management education for 6 months
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria outpatients with chronic pulmonary disease
Key exclusion criteria patients with cognitive impariment, patients who cannot walk 6-minutes, and patients introduced oxygen therapy or changed oxygen flow
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichi Kobayashi
Organization Japanese Red Cross Ishinomaki Hospital
Division name Department of Respiratory Medicine
Zip code
Address 71 Nishimichishita, Hebita, Ishinomaki, Japan
TEL 0225-21-7220
Email skoba-thk@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuko Satou
Organization Japanese Red Cross Ishinomaki Hospital
Division name Clinical study support
Zip code
Address 71 Nishimichishita, Hebita, Ishinomaki, Japan
TEL 0225-21-7220
Homepage URL
Email i-hosp@ishinomaki.jrc.or.jp

Sponsor
Institute Japanese Red Cross Ishinomaki Hospital
Institute
Department

Funding Source
Organization Japanese Red Cross Ishinomaki Hospital
Organization
Division
Category of Funding Organization Self funding
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 石巻赤十字病院

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 07 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 Terminated
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 07 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
2016 Year 01 Month 07 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023655

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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