UMIN-CTR Clinical Trial

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