UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033093 |
|---|---|
| Receipt number | 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 | 2021/06/12 14:52:25 |
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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
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
drodman@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037694
