UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030617 |
|---|---|
| Receipt number | R000034963 |
| Scientific Title | Home medical care support study in patients with Left Ventricular Assist Devices using Social Networking Service. |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2023/03/13 15:49:41 |
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Basic information
Public title
Home medical care support study in patients with Left Ventricular Assist Devices using Social Networking Service.
Acronym
HMCS
Scientific Title
Home medical care support study in patients with Left Ventricular Assist Devices using Social Networking Service.
Scientific Title:Acronym
HMCS
Region
| Japan |
Condition
Condition
Patients with Left Ventricular Assist Devices
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to prevent complications of left ventricular assist device (LVAD) at an early stage by collaborating with LVAD patient, family member and heart failure team by providing home medical care support using SNS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time in therapeutic range (TTR) from baseline to Last follow-up
Key secondary outcomes
(1) Cumulative incidence of LVAD complications that associated with anticoagulation therapy and skin penetration management.
(2) Number of cumulative incidences of other LVAD complications ( Devices trouble, Right heart failure, Aortic regurgitation, Arrhythmia, etc. )
(3) TTR ( 30 days before development of LVAD complications )
(4) All-cause death
(5) Adherence
(6) Number of cumulative onset of other adverse events
(7) Hospital Anxiety and Depression Scale of patients and care givers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Home medical care support using Social Networking Service
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
Heart failure patients with LVAD who completed the home management program (self-management of daily life, wound site, devices and troubleshooting) and evaluated as dischargeable or already discharged from the hospital.
Key exclusion criteria
(1) Without access to a telephone line.
(2) Patients who refused to participate in the study
(3) Patients who are considered not eligible for the study by the attending doctor due to other reasons
Target sample size
5
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
849-8501
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
849-8501
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
None
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
Institutional Review Board,Saga University Hospital
Address
5-1-1 Nabeshima, Saga
Tel
0952343400
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
佐賀大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2020 | 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
| 2017 | Year | 12 | Month | 28 | 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=R000034963
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
