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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032690
Receipt No. R000037281
Scientific Title Low Activities of Daily Living Associated with Increased Cardiovascular Disease Mortality in Japan: An Analysis of Health Records from a Nationwide Claim-Based Database, JROAD-DPC
Date of disclosure of the study information 2018/05/23
Last modified on 2018/05/23

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Basic information
Public title Low Activities of Daily Living Associated with Increased Cardiovascular Disease Mortality in Japan: An Analysis of Health Records from a Nationwide Claim-Based Database, JROAD-DPC
Acronym Clinical impact of activities of daily living
Scientific Title Low Activities of Daily Living Associated with Increased Cardiovascular Disease Mortality in Japan: An Analysis of Health Records from a Nationwide Claim-Based Database, JROAD-DPC
Scientific Title:Acronym Clinical impact of activities of daily living
Region
Japan

Condition
Condition acute coronary disease
heart failure
aortic disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To perform a nationwide claim survey using the DPC discharge database and to reveal the clinical impact of basal ADL on the prognosis of patients with cardiovascular diseases in a super-aged society.
Basic objectives2 Others
Basic objectives -Others To investigate clinilal impact of ADL
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes in-hospital mortality
30-day mortality
7-day mortality
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 acute coronary syndrome
heart failure
aortic disease
Key exclusion criteria scheduled admissions
Target sample size 200000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaomi Gohbara
Organization Saiseikai Yokohamashi Nanbu Hospital
Division name Division of cardiology
Zip code
Address 3-2-10, Kounandai, Kounan-ku, Yokohama, Japan
TEL 045-832-1111
Email gocchi3@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masaomi Gohbara
Organization Saiseikai Yokohamashi Nanbu Hospital
Division name Division of cardiology
Zip code
Address 3-2-10, Kounandai, Kounan-ku, Yokohama, Japan
TEL 045-832-1111
Homepage URL
Email gocchi3@hotmail.com

Sponsor
Institute Saiseikai Yokohamashi Nanbu Hospital
Institute
Department

Funding Source
Organization Yokohama City University
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 23 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The Japanese Registry of All Cardiac and Vascular Diseases (JROAD) was launched in 2004 to assess the clinical activity of each Japanese institution with cardiovascular beds. The Japanese Circulation Society publicly advertised for the research proposal using the JROAD and the JROAD-DPC. The present study was adopted as the 2016 research proposal (approval number: 2016-12-02).

Management information
Registered date
2018 Year 05 Month 23 Day
Last modified on
2018 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037281

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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