UMIN-CTR Clinical Trial

Basic information
Public title	The effect of comprehensive respiratory rehabilitation using cloud system on exacerbation of patients with chronic obstructive pulmonary disease at home
Acronym	The effect of cloud system on exacerbation of patients with chronic obstructive pulmonary disease
Scientific Title	The effect of comprehensive respiratory rehabilitation using cloud system on exacerbation of patients with chronic obstructive pulmonary disease at home
Scientific Title:Acronym	The effect of cloud system on exacerbation of patients with chronic obstructive pulmonary disease
Region	Japan

Condition
Condition	Chronic obstructive pulmonary disease
Classification by specialty	Pneumology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to clarify whether to prevent exacerbation by comprehensive respiratory rehabilitation at home using cloud system
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of exacerbations of chronic obstructive pulmonary disease 24 months after randomization
Key secondary outcomes	Daily physical activity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	For the intervention group,comprehensive respiratory rehabilitation is performed using a multi-occupational cooperation tool by Vital Link (Teijin Pharma, Tokyo),and the control group is treated as usual. The program is about 1.exercise therapy, 2. Physical activity instruction in daily life, 3. Patient education, and when intervening at the time of visit, the nurse and the caregiver confirm and intervene the contents of 1 - 3. After the intervention, the nurse and the caregiver states Program implementation status, content change and continuation.
Interventions/Control_2	Performing a usual care in the control group
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	65 years-old <=
Age-upper limit	120 years-old >
Gender	Male and Female
Key inclusion criteria	50 subjects who are in a stable period not suffering from exacerbations and infectious diseases such as pneumonia in patients with chronic obstructive pulmonary disease (COPD) who are seeking a Shinshu University Medical School affiliated hospital or a research cooperation facility (to be recruited) . Those that meet the eligibility criteria of 1 to 4 below are targeted. 1. Patients aged 65 years or older diagnosed with COPD (Guidelines for Diagnosis and Treatment of COPD 4th Edition, Japan Respiratory Society) 2. Shinshu University Medical School Hospital for the purpose of diagnosis and treatment of COPD Patients who visited research collaborative facilities (to be recruited) 3. Patients who obtained informed consent for this study 4. Patients who are involved in visiting rehabilitation, nursing caregivers, or caregivers
Key exclusion criteria	1. Patients suffering from exacerbation and respiratory infection within 3 months 2. Patients who are impaired in walking or writing on question paper due to the influence of exercise function or cognitive function or difficult patients 3. Patients with complications such as severe heart failure
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shohei Kawachi
Organization	Shinshu university hospital
Division name	Rehabilitation department
Zip code
Address	3-1-1 Asahi, Matsumoto Nagano Japan 390-8621
TEL	0263-37-2836
Email	drodman@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shohei Kawachi
Organization	Shinshu university hospital
Division name	Rehabilitation department
Zip code
Address	3-1-1 Asahi, Matsumoto Nagano Japan 390-8621
TEL	0263-37-2836
Homepage URL
Email	drodman@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University School of Health Sciences
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2018 Year 07 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	Completed
Date of protocol fixation	2018 Year 07 Month 01 Day
Date of IRB	2018 Year 06 Month 05 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2018 Year 07 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	2018 Year 06 Month 21 Day
Last modified on	2021 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037694