UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024782
Receipt number R000028460
Scientific Title Saga Home Telemonitoring Study for Heart Failure
Date of disclosure of the study information 2016/11/10
Last modified on 2023/03/13 15:46:36

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Basic information

Public title

Saga Home Telemonitoring Study for Heart Failure

Acronym

S-HOMES

Scientific Title

Saga Home Telemonitoring Study for Heart Failure

Scientific Title:Acronym

S-HOMES

Region

Japan


Condition

Condition

Heart Failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Home Telemonitoring system would lead to early detection of cardiac exacerbation, and consequently reduce the risk of readmission.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.all-cause death
2.Rehospitalization for heart failure

Key secondary outcomes

1.Clinical scenario at the time of rehospitalization
2.Weight change untildeath or rehospitalization
3.%changes of NT-proBNP,BNP
4.Heart failure symptoms(NYHA,edema)
5.%changes of echocardiographic index (EF, LVDd, LVDs,diastolic function)
6.Adherence
7.Attitude modification,Behavioral modification


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

Other

Interventions/Control_1

Home Telemonitoring system

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

1.Patients with history of hospitalization or rehospitalization with acute or chronic heart failure exacerbation
2.New York Heart Association functional classes II-IV
3.Age >= 20 years

Key exclusion criteria

1.Sever depression (Patient Health Questionnaire scores >= 20),Sever dementia
2.Pregnancy
3.Physical disorder
4.Without access to a telephone line
5.Patients who refused to participate in the study
6.Patients who are considered not eligible for the study by the attending doctor due to other reasons


Target sample size

60


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Node

Organization

Saga University

Division name

Department of Cardiovascular Medicine

Zip code

849-0051

Address

5-1-1 Nabeshima, Saga

TEL

0952-34-2364

Email

node@cc.saga-u.ac.jp


Public contact

Name of contact person

1st name Koichi
Middle name
Last name Node

Organization

Saga University

Division name

Department of Cardiovascular Medicine

Zip code

849-0051

Address

5-1-1 Nabeshima, Saga

TEL

0952-34-2364

Homepage URL


Email

cardiostudy@ml.cc.saga-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Saga University

Institute

Department

Personal name



Funding Source

Organization

Saga Prefectural Government
Asahi Kasei corporation

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research Center,Saga University Hospital

Address

5-1-1 Nabeshima, Saga

Tel

0952343357

Email

kenkyu-shinsei@ml.cc.saga-u.ac.jp


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

済生会唐津病院
医療法人大和正信会 ふじおか病院


Other administrative information

Date of disclosure of the study information

2016 Year 11 Month 10 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

43

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 10 Month 07 Day

Date of IRB

2016 Year 11 Month 16 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2019 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 11 Month 10 Day

Last modified on

2023 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028460


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name