UMIN-CTR Clinical Trial

Basic information
Public title	The study of COPD self-management education apps : a randomized controlled superiority trial
Acronym	The study of COPD self-management education apps : a randomized controlled superiority trial
Scientific Title	The development of a new generation application for iPad for interactive education to COPD patients on personalized self-management: a randomized controlled superiority trial
Scientific Title:Acronym	The effect of self-management education program to COPD by application
Region	Japan

Condition
Condition	Chronic Obstructive Pulmonary Disease ; COPD
Classification by specialty	Pneumology Rehabilitation medicine Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of application-based self-management in patients with COPD patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	St George's Hospital Respiratory Questionnaire :SGRQ
Key secondary outcomes	6-minute walk test Borg CR-10(Category-Ratio 10) Lung Information Needs Questionnaire Daily steps count

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	The ordinary care and self-management education by app for 4month
Interventions/Control_2	Ordinary 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The COPD patients above the severity of moderate(GOLD 2)
Key exclusion criteria	The exclusion criteria were those on pulmonary rehabilitation within 1 year, having an episode of exacerbation within 30 days of the trial start day and having complicated comorbidities such as bronchial asthma, ischemic heart disease, unstable hypertension, orthopedic or neurovascular disorders with walking impairment, and dementia
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Emika Middle name Last name Sano
Organization	Kyorin University
Division name	Department of Nursing, Faculty of Health Sciences
Zip code	181-8612
Address	5-4-1 Shimorenjaku,Mitaka-shi,Tokyo,Japan
TEL	0422-47-8000
Email	esano@ks.kyorin-u.ac.jp

Public contact
Name of contact person	1st name Emika Middle name Last name Sano
Organization	Kyorin University
Division name	Department of Nursing, Faculty of Health Sciences
Zip code	181-8612
Address	5-4-1 Shimorenjaku,Mitaka-shi,Tokyo,Japan
TEL	0422-47-8000
Homepage URL
Email	esano@ks.kyorin-u.ac.jp

Sponsor
Institute	Kyorin University
Institute
Department

Funding Source
Organization	None
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	Ethical Review Board of Juntendo University Urayasu Hospital
Address	2-1-1 Tomioka, Urayasu City, Chiba
Tel	047-353-31112
Email	N/A

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	順天堂大学医学部附属浦安病院（千葉県）

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 05 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	57
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	Completed
Date of protocol fixation	2014 Year 03 Month 18 Day
Date of IRB	2014 Year 04 Month 10 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 05 Day
Last modified on	2021 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049377