UMIN-ICDS 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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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