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 | 2025/01/28 10:47:01 |
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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
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
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
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
Main results already published
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
| 2025 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028460
