UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Efficacy of the Telephone Interventions by Trained Device Nurses for the Implantable Cardioverter Defibrillator Recipients
Title of the study (Brief title)	The Efficacy of the Telephone Interventions by Trained Device Nurses for the Implantable Cardioverter Defibrillator 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 telephone interventions by the trained nurses for the patients' better self-adjustment to the cardiac defibrillators
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To show the efficacy of the telephone interventions by the trained nurses for the patients' better self-adjustment to the cardiac defibrillators
Key secondary outcomes	To show the efficacy of the telephone interventions by the trained nurses for the patients' better QOL and anxiety score, and the rate of accidental admissions are also evaluated

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 takes a contact with the patient via telphone interview.
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. Ptients with shock device treated with remortmonitaring system 2. age>=20yo 3. informed consent can be obtained
Key exclusion criteria	1. patients not agree to particitating this study 2. patients not suitable for this study
Target sample size	250

Research contact person
Name of lead principal investigator	Koji FUKUZAWA
Organization	Kobe University Graduate School of Medicine
Division name	Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine
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	Koji FUKUZAWA
Organization	Kobe University Graduate School of Medicine
Division name	Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine
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 Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

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

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

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	神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 07 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 08 Day
Anticipated trial start date	2017 Year 07 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 11 Month 07 Day
Last modified on	2018 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030465