UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020481 |
|---|---|
| Receipt number | 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 17:20:46 |
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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
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
i-hosp@ishinomaki.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Ishinomaki Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023655
