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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039602
Receipt No. 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

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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
Email 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
Email cardiostudy@ml.cc.saga-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Saga University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044282

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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