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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040401
Receipt No. R000046104
Scientific Title A feasibility study of remote rehabilitation using a wearable biological monitoring device in the patients with COVID-19
Date of disclosure of the study information 2020/05/15
Last modified on 2020/05/14

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Basic information
Public title A feasibility study of remote rehabilitation using a wearable biological monitoring device in the patients with COVID-19
Acronym A feasibility study of remote rehabilitation using a wearable device in COVID-19 patients
Scientific Title A feasibility study of remote rehabilitation using a wearable biological monitoring device in the patients with COVID-19
Scientific Title:Acronym A feasibility study of remote rehabilitation using a wearable device in COVID-19 patients
Region
Japan

Condition
Condition COVID-19
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Confirmation that remote rehabilitation under remote monitoring can be performed safely
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes remote rehabilitation under remote monitoring can be performed safely
Key secondary outcomes

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Wearable biological monitoring device
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria New coronavirus infection patients undergoing remote rehabilitation
Key exclusion criteria Patients judged to be inappropriate by the investigato
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tomoyuki
Middle name
Last name Umemoto
Organization Tokyo Medical and Dental University
Division name Department of Cardiovascular Medicine
Zip code 1138519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519
TEL 03-5803-5231
Email umemoto.cvm@tmd.ac.jp

Public contact
Name of contact person
1st name Tomoyuki
Middle name
Last name Umemoto
Organization Tokyo Medical and Dental University
Division name Department of Cardiovascular Medicine
Zip code 1138519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519
TEL 03-5803-5231
Homepage URL
Email umemoto.cvm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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 Medical Research Ethics Committee of Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519
Tel 03-5803-5096
Email info.bec@tmd.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
2020 Year 05 Month 15 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
2020 Year 05 Month 15 Day
Date of IRB
2020 Year 05 Month 15 Day
Anticipated trial start date
2020 Year 05 Month 15 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 05 Month 14 Day
Last modified on
2020 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046104

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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