UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023098 |
|---|---|
| Receipt number | R000026510 |
| Scientific Title | Determination of face-to-face medical care intervals for domiciliary oxygen therapy with remote monitoring system |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2017/08/08 19:17:53 |
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Basic information
Public title
Determination of face-to-face medical care intervals for domiciliary oxygen therapy with remote monitoring system
Acronym
Determination of face-to-face medical care intervals for domiciliary oxygen therapy with remote monitoring system
Scientific Title
Determination of face-to-face medical care intervals for domiciliary oxygen therapy with remote monitoring system
Scientific Title:Acronym
Determination of face-to-face medical care intervals for domiciliary oxygen therapy with remote monitoring system
Region
| Japan |
Condition
Condition
Chronic respiratory failure
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that it is possible to keep the treatment adherence for domiciliary oxygen therapy by using the remote monitoring system while the face-to-face medical care intervals are extended.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The dairy average usage time of oxygen concentrator during four months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention: During four months, we review the dairy usage data of domiciliary oxygen therapy monthly by the remote monitoring system and give the study subjects guidance alternatively through face-to-face medical cares and telemedicine every month.
Interventions/Control_2
Control: During four months, we give the study subjects guidance through monthly face-to-face medical cares. Although we collect the dairy usage data of domiciliary oxygen therapy by the remote monitoring system, we do not use the data for medical cares during the study period.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We recruit outpatients having chronic respiratory failure caused by any pulmonary disease and receiving 24-hour domiciliary oxygen therapy. Patients can be included regardless of the causative pulmonary disease or the given dose of oxygen as far as they have already received 24-hour domiciliary oxygen therapy and monthly or bimonthly face-to-face medical cares for three or more months at the outpatient setting. At the time of enrollment, study participants are also required to have used the remote monitoring system as a part of clinical practice. Any remote monitoring system and any supplier and provider of the system are acceptable as far as the system can monitor the usage time of oxygen concentrator. Although it does not matter when the system started to work, the usage data of oxygen concentrator during the preceding month are necessary at enrollment.
Key exclusion criteria
Patients are excluded when 1) they need to receive monthly or more frequent face-to-face medical cares for other reasons than domiciliary oxygen therapy management from the same physicians, 2) they were hospitalized within the preceding three months because of any pulmonary disease, 3) they are receiving home mechanical ventilation or continuous positive airway pressure therapy, 4) they have any active malignant neoplasm, 5) their cognitive functions are impaired enough to prevent them from completing the questionnaires or understanding the guidance through telemedicine or 6) they have been already scheduled for hospitalization during the study period.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Chin |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Respiratory Care and Sleep Control Medicine
Zip code
Address
54 Shogoin-kawaracho, Sakyo-ku, Kyoto
TEL
075-751-3852
chin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiminobu Tanizawa |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Respiratory Care and Sleep Control Medicine
Zip code
Address
54 Shogoin-kawaracho, Sakyo-ku, Kyoto
TEL
075-751-3852
Homepage URL
enkaku@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine,
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 07 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2017 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026510
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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