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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033093
Receipt No. R000037694
Scientific Title The effect of comprehensive respiratory rehabilitation using cloud system on exacerbation of patients with chronic obstructive pulmonary disease at home
Date of disclosure of the study information 2018/07/01
Last modified on 2018/06/21

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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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 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
2018 Year 06 Month 21 Day
Last modified on
2018 Year 06 Month 21 Day


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

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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