UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028283 |
|---|---|
| Receipt number | 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 | 2020/03/11 21:42:35 |
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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 | Hiroyuki |
| Middle name | |
| Last name | Tsutsui |
Organization
Kyushu University, Graduate School of Medical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL
092-642-5357
tomomi_i@cardiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Ide |
Organization
Kyushu University, Graduate School of Medical Sciences.
Division name
Department of Cardiovascular Medicine
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL
092-642-5357
Homepage URL
tomomi_i@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University, Graduate School of Medical Sciences
Institute
Department
Personal name
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
Kyushu University Hospital Ethics Committee
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel
81-92-642-5774
tomomi_i@cardiol.med.kyushu-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
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
| 2017 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 11 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 19 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031797
