UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Self-management education using cosecutive pulse oximetery for outpatients with chronic pulmonary disease
Title of the study (Brief title)	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	Seiichi Kobayashi
Organization	Japanese Red Cross Ishinomaki Hospital
Division name	Department of Respiratory Medicine
Address	71 Nishimichishita, Hebita, Ishinomaki, Japan
TEL	0225-21-7220
Email	skoba-thk@umin.ac.jp

Public contact
Name of contact person	Yasuko Satou
Organization	Japanese Red Cross Ishinomaki Hospital
Division name	Clinical study support
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 01 Day
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

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Publication of results	Unpublished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