UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034804
Receipt number R000030465
Scientific Title 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 16:18:22

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Basic information

Public title

The Efficacy of the Telephone Interventions by Trained Device Nurses for the Implantable Cardioverter Defibrillator Recipients

Acronym

The Efficacy of the Telephone Interventions by Trained Device Nurses for the Implantable Cardioverter Defibrillator Recipients

Scientific Title

The Efficacy of the Telephone Interventions by Trained Device Nurses for the Implantable Cardioverter Defibrillator Recipients

Scientific Title:Acronym

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

1st name
Middle name
Last name Koji FUKUZAWA

Organization

Kobe University Graduate School of Medicine

Division name

Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine

Zip code


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
Middle name
Last name Koji FUKUZAWA

Organization

Kobe University Graduate School of Medicine

Division name

Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine

Zip code


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 or person

Institute

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

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Enrolling by invitation

Date of protocol fixation

2017 Year 06 Month 08 Day

Date of IRB


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



Other

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

Value
https://center6.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