UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012753 |
|---|---|
| Receipt number | R000014892 |
| Scientific Title | The evaluation of psychological quality of life in patients with implantable cardioverter-defibrillators |
| Date of disclosure of the study information | 2014/01/05 |
| Last modified on | 2014/01/04 16:40:19 |
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Basic information
Public title
The evaluation of psychological quality of life in patients with implantable cardioverter-defibrillators
Acronym
The evaluation of psychological quality of life in patients with implantable cardioverter-defibrillators
Scientific Title
The evaluation of psychological quality of life in patients with implantable cardioverter-defibrillators
Scientific Title:Acronym
The evaluation of psychological quality of life in patients with implantable cardioverter-defibrillators
Region
| Japan |
Condition
Condition
Ventricular tachycardia, Ventricular fibrillation, Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of affecting factors on psychological quality of life in implantable cardioverter-defibrillator patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Florida Shock Anxiety Scale
Key secondary outcomes
Hospital Anxiety and Depression Scale, Montgomery-Asberg Depression Rating Scale
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
The examination by the psychiatrist
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
Patient who is planing to receive implantation of ICD or CRT-D
Key exclusion criteria
Patient who isn't got informed consent, or was diagnosed with depression before, or patient whom doctor considers inappropriate
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Kobayashi |
Organization
Chiba University graduate school of medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1,inohana,chuou-ku,chiba-shi,chiba prefecture
TEL
043-222-7171
wydhx562@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Miyazawa |
Organization
Chiba University graduate school of medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1,inohana,chuou-ku,chiba-shi,chiba prefecture
TEL
043-222-7171
Homepage URL
wydhx562@yahoo.co.jp
Sponsor or person
Institute
Chiba University graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Chiba University graduate school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 01 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 19 | 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
| 2014 | Year | 01 | Month | 04 | Day |
Last modified on
| 2014 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014892
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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