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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024782
Receipt No. R000028460
Scientific Title Saga Home Telemonitoring Study for Heart Failure
Date of disclosure of the study information 2016/11/10
Last modified on 2019/08/26

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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 Norihiko
Middle name
Last name Kotooka
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
Institute Department of Cardiovascular Medicine, Saga University
Institute
Department

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
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.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


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