UMIN-CTR Clinical Trial

Basic information
Public title	The Efficacy of Nursing Intervention by Trained Device Nurses for the Implantable Cardiaoverter Defibrillator Newly Recipients
Acronym	The Efficacy of Nursing Intervention by Trained Device Nurses for the Implantable Cardiaoverter Defibrillator Newly Recipients
Scientific Title	The Efficacy of Nursing Intervention by Trained Device Nurses for the Implantable Cardiaoverter Defibrillator Newly Recipients
Scientific Title:Acronym	The Efficacy of Nursing Intervention by Trained Device Nurses for the Implantable Cardiaoverter Defibrillator Newly Recipients
Region	Japan

Condition
Condition	Implantable Cardioverter Defibrillator Recipients
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To show the efficacy of the nursing supprt and self-management support by the trained nurses for the patients' better self-adjustment to the cardiac defibrillators
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To show the efficacy of the nursing supprt and self-management support by the trained nurses for the patients' better self-adjustment to the cardiac defibrillators
Key secondary outcomes	To show the efficacy of the nursing supprt and self-management support by the trained nurses for the better POMS2 score, QOL score,"Activity" and "Sleep" 6 months after discharge

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
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	Device nurse suppots the patient 1 month, 6 months, 1 year after discharge and implantation.The life rhythm was assessed by the life rhythm meter (ActiGraph Link) and nersing intervantion was performed at 6 months after implantation.
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	1.Patients who implant implantable heart devices with new defibrillation function 2.age>=20yo 3.Outpatient of the facility 4.informed consent can be obtained
Key exclusion criteria	1.difficult walking independently 2.difficult to answer 3.patients not suitable for this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Fukuzawa
Organization	Kobe University Graduate School of Medicine
Division name	Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code	650-0017
Address	650-0017,Kusunoki-Cho 7-5-2,Chuoh-Ku,Kobe,Japan
TEL	078-382-5846
Email	kfuku@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Fukuzawa
Organization	Kobe University Graduate School of Medicine
Division name	Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code	650-017
Address	650-0017,Kusunoki-Cho 7-5-2,Chuoh-Ku,Kobe,Japan
TEL	078-382-5846
Homepage URL
Email	kfuku@med.kobe-u.ac.jp

Sponsor
Institute	Section of Arrhythmia,Division of Cardiovascular Meicine,Department of Internal Medicine,Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Biotronik JAPAN
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Biotronik JAPAN
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Clinical Ethics Committee Secretariat
Address	650-0017 Kusunoki-Cho 7-5-2,Chuoh-Ku,Kobe,Japan
Tel	078-382-6669
Email	kainyun@med.kobe-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

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 01 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	2019 Year 12 Month 01 Day
Date of IRB	2019 Year 12 Month 01 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2025 Year 03 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	2019 Year 11 Month 21 Day
Last modified on	2022 Year 05 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044022