UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041421 |
|---|---|
| Receipt number | R000047290 |
| Scientific Title | Detecting Exacerbation Early Signs of SARS-CoV-2 infection by Fitbit: Pilot Study |
| Date of disclosure of the study information | 2020/08/14 |
| Last modified on | 2022/04/11 13:56:38 |
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Basic information
Public title
Detecting Exacerbation Early Signs of SARS-CoV-2 infection by Fitbit: Pilot Study
Acronym
DEXTERITY Fitbit Pilot Study
Scientific Title
Detecting Exacerbation Early Signs of SARS-CoV-2 infection by Fitbit: Pilot Study
Scientific Title:Acronym
DEXTERITY Fitbit Pilot Study
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will use a wearable device to acquire biometric data of patients diagnosed with COVID-19 by PCR to observe the trend of biometric data in the natural course of COVID-19 infection and to search for variations in biometric data to predict the exacerbation of the disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite of relapse of COVID-19-like symptoms that did not lead to hospitalization, readmission due to COVID-19-like symptoms, oxygen administration, intubation/ventilator use, ECMO use, or all-cause death
Key secondary outcomes
1) Relapse of COVID-19-like symptoms that did not lead to hospitalization
2) Readmission due to COVID-19-like symptoms
3) Oxygen administration
4) Intubation/ventilator use
5) ECMO use
6) All-cause death
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
Patients diagnosed with COVID-19 by positive SARS-CoV-2 PCR test results within 1 week of study enrollment
Key exclusion criteria
1) Unable to wear and use a wearable device
2) Unable to use a smartphone and a smartphone app to connect the wearable device
3) COVID-19 patients with serious condition as ventilator use at registration and unable to obtain informed consent from the patient
4) Others who are deemed unsuitable to include in this study by the principal investigator or sub-investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Nomura |
Organization
Kanazawa University
Division name
Innovative Clinical Research Center (iCREK) / Department of Cardiovascular Medicine
Zip code
920-8641
Address
13-1 Takaramachi Kanazawa Ishikawa
TEL
076-265-2049
anomura@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Nomura |
Organization
Kanazawa University
Division name
Innovative Clinical Research Center (iCREK) / Department of Cardiovascular Medicine
Zip code
920-8641
Address
13-1 Takaramachi Kanazawa Ishikawa
TEL
076-265-2049
Homepage URL
anomura@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Innovative Clinical Research Center, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Fitbit Japan
IRB Contact (For public release)
Organization
Kanazawa University Independent Ethics Committee
Address
13-1 Takaramachi Kanazawa Ishikawa
Tel
076-265-2110
rinri@adm.kanazawa-u.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
金沢大学附属病院(石川県)
JCHO金沢病院(石川県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
https://formative.jmir.org/2021/9/e30819/PDF
Number of participants that the trial has enrolled
29
Results
Please see the manuscript via the link above
Results date posted
| 2021 | Year | 02 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 09 | Month | 16 | Day |
Baseline Characteristics
Please see the manuscript via the link above
Participant flow
Please see the manuscript via the link above
Adverse events
Please see the manuscript via the link above
Outcome measures
Please see the manuscript via the link above
Plan to share IPD
Please see the manuscript via the link above
IPD sharing Plan description
Please see the manuscript via the link above
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 05 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 05 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Please see the manuscript via the link above
Management information
Registered date
| 2020 | Year | 08 | Month | 14 | Day |
Last modified on
| 2022 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047290
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
