UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Determination of face-to-face medical care intervals for Adaptive Servo Ventilation (ASV) therapy with remote monitoring system in patients with chronic heart failure
Title of the study (Brief title)	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	Kazuo Chin
Organization	Kyoto University, Graduate School of Medicine
Division name	Department of Respiratory Care and Sleep Control Medicine
Address	54 Shogoin-kawaracho, Sakyo-ku, Kyoto
TEL	075-751-3852
Email	chin@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Kimihiko Murase
Organization	Kyoto University, Graduate School of Medicine
Division name	Department of Respiratory Care and Sleep Control Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 09 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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