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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028283
Receipt No. R000031797
Scientific Title The efficacy of information and communication technology(ICT)-based telecare in patients undergoing continuous-flow left ventricular assist device (LVAD) implantation.
Date of disclosure of the study information 2017/07/20
Last modified on 2017/07/19

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Basic information
Public title The efficacy of information and communication technology(ICT)-based telecare in patients undergoing continuous-flow left ventricular assist device (LVAD) implantation.
Acronym The efficacy of ICT-based telecare in patients undergoing LVAD implantation.(IT-LVAD)
Scientific Title The efficacy of information and communication technology(ICT)-based telecare in patients undergoing continuous-flow left ventricular assist device (LVAD) implantation.
Scientific Title:Acronym The efficacy of ICT-based telecare in patients undergoing LVAD implantation.(IT-LVAD)
Region
Japan

Condition
Condition Heart Failure, LVAD, Heart Trasnplantation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine the efficacy of telecare used ICT in patients undergoing LVAD implantation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of communication with telephone, E-mail and FAX from patients to medical staffs in a month.
Key secondary outcomes The number of hospital visit. (per month.)
The number of unscheduled hospital visits.
The number of urgent hospitalization.
The number of communication with ICT.
The questionnaire of self-efficacy, QOL and the satisfaction degree.

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
Device,equipment
Interventions/Control_1 ICT-based telecare
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Ambulatory patients undergoing LVAD implantation and discharged before 60 days or more.
Using smartphone, tablet routinely.
Key exclusion criteria having difficulty in using smartphone.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Tsutsui
Organization Kyushu University, Graduate School of Medical Sciences
Division name Department of Cardiovascular Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL 092-642-5357
Email tomomi_i@cardiol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomomi Ide
Organization Kyushu University, Graduate School of Medical Sciences.
Division name Department of Cardiovascular Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL 092-642-5357
Homepage URL
Email tomomi_i@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University, Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 20 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
2017 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 03 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
2017 Year 07 Month 19 Day
Last modified on
2017 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031797

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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