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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043390
Receipt No. R000049540
Scientific Title Development of a flail evaluation application based on deep learning
Date of disclosure of the study information 2021/02/19
Last modified on 2021/02/19

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Basic information
Public title Development of a flail evaluation application based on deep learning
Acronym Development of a flail evaluation application based on deep learning
Scientific Title Development of a flail evaluation application based on deep learning
Scientific Title:Acronym Development of a flail evaluation application based on deep learning
Region
Japan

Condition
Condition Chronic Heart Failure
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop an application for evaluating frailty based on objective evidence that can be used on smartphones and tablet devices.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of flail estimated by deep learning with existing indicators.
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 1) Flail group
Patients who have given written consent for the recording of walking videos at Hokkaido University Hospital and other collaborating facilities in the previously approved clinical research project "Epidemiological Multicenter Study for Tailored Treatment in Heart Failure".
2)Healthy group
Patients must have no history of heart failure, be 20 years of age or older at the time of consent, and have a score of 1 or 2 on the Clinical Frailty Scale. The recruitment of the healthy group will be done by posting posters in the hospital.
Key exclusion criteria (1) Frail group
1) Those who are judged by the principal investigator to be inappropriate as research subjects
(2) Healthy group
1) Those who are under 20 years of age at the time of obtaining consent
2) Those who are judged by the principal investigator to be inappropriate as research subjects.
3) Those with a score of 3 or more on the Clinical Frailty Scale
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name Toshiyuki
Middle name
Last name Nagai
Organization Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name Department of Cardiovascular Medicine
Zip code 060-8638
Address Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL 011-706-6973
Email nagai@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Yoshifumi
Middle name
Last name Mizuguchi
Organization Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name Department of Cardiovascular Medicine
Zip code 060-8638
Address Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL 011-706-6973
Homepage URL
Email mizu-tay@med.hokudai.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Institute
Department

Funding Source
Organization Non profit foundation
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hokkaido University Faculty of Medicine and Graduate School of Medicine Independent Clinical Research Review Committee
Address Kita 15 Nishi 7, Kita-ku, Sapporo, Hokkaido
Tel 011-706-5003
Email shomu@med.hokudai.ac.jp

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
2021 Year 02 Month 19 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
2020 Year 11 Month 27 Day
Date of IRB
2020 Year 11 Month 27 Day
Anticipated trial start date
2020 Year 11 Month 27 Day
Last follow-up date
2030 Year 03 Month 31 Day
Date of closure to data entry
2035 Year 03 Month 31 Day
Date trial data considered complete
2035 Year 03 Month 31 Day
Date analysis concluded
2035 Year 03 Month 31 Day

Other
Other related information none

Management information
Registered date
2021 Year 02 Month 19 Day
Last modified on
2021 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049540

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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