UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034166
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email enkaku@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Respiratory Care and Sle ep Control Medicine, Kyoto University, Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038923

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.