UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034166 |
|---|---|
| Receipt number | R000038923 |
| Scientific Title | Determination of face-to-face medical care intervals for Adaptive Servo Ventilation (ASV) therapy with remote monitoring system in patients with chronic heart failure |
| Date of disclosure of the study information | 2018/09/18 |
| Last modified on | 2018/09/16 03:50:24 |
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Basic information
Public title
Determination of face-to-face medical care intervals for Adaptive Servo Ventilation (ASV) therapy with remote monitoring system in patients with chronic heart failure
Acronym
Determination of face-to-face medical care intervals for ASV therapy with remote monitoring system
Scientific Title
Determination of face-to-face medical care intervals for Adaptive Servo Ventilation (ASV) therapy with remote monitoring system in patients with chronic heart failure
Scientific Title:Acronym
Determination of face-to-face medical care intervals for ASV therapy with remote monitoring system
Region
| Japan |
Condition
Condition
Chronic herart 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 Adaptive Servo Ventilation (ASV) therapy in patients with chronic heart failure 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
Change in treatment adherence for Adaptive Servo Ventilation (ASV) therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
During six months, we review the usage data of ASV therapy (the rate of days of ASV usage with four or more hours per day, the average usage time, the average apnea hypopnea index (AHI) per month) monthly by the remote monitoring system. We give the study subjects guidance through face-to-face medical cares every three months. At the months without face-to-face medical cares, we give the patients guidance through telemedicine.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We recruit outpatients having chronic heart failure (NYHA grade 2 or more) and receiving ASV therapy. Patients can be included regardless of the indication for ASV therapy as far as they have already received ASV therapy and monthly or bimonthly face-to-face medical cares for three or more months at the outpatient setting, under the coverage by the national insurance service in Japan.
At the time of enrollment, the usage data of ASV therapy within the preceding 28 days are necessary. Any remote monitoring system and any supplier and provider of the system are acceptable as far as the system can monitor the usage data of ASV therapy and has started to work at the time of baseline (the start of study).
Patients can be included only when there has been no change in medication for heart failure within the previous three months and no admission for heart failure within the previous six months.
Key exclusion criteria
Patients are excluded when 1) they have cognitive impairment, 2) they have any history of cerebrovascular disease with residual neurological disabilities, 3) they need to receive monthly or more frequent face-to-face medical cares for ASV management from the same physicians, 4) they have been already scheduled for hospitalization during the study periods, 5) they have been already scheduled for changing treatment for heart failure, 6) 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, 7) they have any active malignant neoplasm, 8) they are receiving chronic hemodialysis, or 9) they are receiving domiciliary oxygen therapy.
Target sample size
61
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 | Kimihiko Murase |
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 Sle ep 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
| 2018 | Year | 09 | Month | 18 | 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 | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | 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 | 09 | Month | 16 | Day |
Last modified on
| 2018 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038923
