UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039602 |
|---|---|
| Receipt number | R000044282 |
| Scientific Title | Examination of an effective education method for patients with assistive artificial heart and caregivers |
| Date of disclosure of the study information | 2020/02/27 |
| Last modified on | 2021/07/07 16:35:17 |
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Basic information
Public title
Examination of an effective education method for patients with assistive artificial heart and caregivers
Acronym
Examination of an effective education method for patients with assistive artificial heart and caregivers
Scientific Title
Examination of an effective education method for patients with assistive artificial heart and caregivers
Scientific Title:Acronym
Examination of an effective education method for patients with assistive artificial heart and caregivers
Region
| Japan |
Condition
Condition
Implantable ventricular assist device
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The e-learning system is used to educate patients with implantable ventricular assist devices and caregivers, and the effectiveness of the education will be demonstrated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before starting e-learning, compare written results and skill check test results after e-learning learning (after 5 weeks)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Equipment management education by e-learning
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
Patients and caregivers wearing implantable assistive hearts (Abbott HeartMate2)
Key exclusion criteria
(1) Patients judged by the attending physician to be unable to participate in the study
(2) Patients who cannot obtain written consent from the person
Target sample size
22
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
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Cardiovascular Medicine, Nagasaki University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board Saga University
Address
5-1-1 Nabeshima, Saga City, Saga Prefecture
Tel
0952-34-3357
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（佐賀県）
長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
The average score of both the written and practical test results before and after the introduction increased.
In the questionnaire, neither users nor educators answered that they were dissatisfied with their satisfaction, which was generally well received.
Results date posted
| 2021 | Year | 07 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients and caregivers wearing implantable assistive hearts (Abbott HeartMate2)
Participant flow
(1) Patients judged by the attending physician to be unable to participate in the study
(2) Patients who cannot obtain written consent from the person
Only those who were able to participate due to the above two points became participants
Adverse events
No adverse events were observed.
Outcome measures
Before starting e-learning, compare written results and skill check test results after e-learning learning (after 5 weeks)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 07 | 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
| 2020 | Year | 02 | Month | 26 | Day |
Last modified on
| 2021 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044282
| 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 |
