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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034804
Receipt No. R000030465
Official scientific title of the study The Efficacy of the Telephone Interventions by Trained Device Nurses for the Implantable Cardioverter Defibrillator Recipients
Date of disclosure of the study information 2018/11/07
Last modified on 2018/11/07

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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

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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