UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036122 |
|---|---|
| Receipt number | R000041146 |
| Scientific Title | evaluation of medical worker's daytime activity and sleep using a fitness tracker. |
| Date of disclosure of the study information | 2019/03/10 |
| Last modified on | 2019/03/07 23:05:15 |
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Basic information
Public title
evaluation of medical worker's daytime activity and sleep using a fitness tracker.
Acronym
daytime activity and sleep
Scientific Title
evaluation of medical worker's daytime activity and sleep using a fitness tracker.
Scientific Title:Acronym
daytime activity and sleep
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct a suitable on-off balance model for medical workers by observing the patterns of daytime activities and sleep.
Basic objectives2
Others
Basic objectives -Others
Use of fitness tracker that enables noninvasive and continuous monitoring.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective evaluation of medical worker's daytime activity and sleep.
Daytime activity: awake hours, energy, heart rate
Sleep: sleep hours, awake hours during sleep, hours of each sleep stage
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
fitness tracker
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
Medical worker in the ICU
Key exclusion criteria
No consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motomu Shimaoka |
Organization
Mie University Graduate School of Medicine
Division name
Dept of Molecular Pathobiology and Cell Adhesion Biology
Zip code
Address
2-174 Edobashi Tsu-City Mie 514-8507, Japan
TEL
+81-59-231-5031
shimaoka@doc.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asami Ito |
Organization
Mie University Hospital
Division name
Emergency and Critical Care Center
Zip code
Address
2-174 Edobashi Tsu-City Mie 514-8507, Japan
TEL
+81-59-232-1111
Homepage URL
amasui@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Mie 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
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
| 2019 | Year | 03 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | 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
| 2019 | Year | 03 | Month | 07 | Day |
Last modified on
| 2019 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041146
| Research Plan | |
|---|---|
| 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 |
