UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033894 |
|---|---|
| Receipt number | R000038307 |
| Scientific Title | Effectiveness of virtual personal assistant system supporting mental and physical health for workers |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2018/08/24 14:02:53 |
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Basic information
Public title
Effectiveness of virtual personal assistant system supporting mental and physical health for workers
Acronym
TOSCK project
Scientific Title
Effectiveness of virtual personal assistant system supporting mental and physical health for workers
Scientific Title:Acronym
TOSCK project
Region
| Japan |
Condition
Condition
low back pain, shoulder and neck discomfort
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify improvement of mental and physical health using the virtual personal assistant system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective symptoms of neck and shoulder discomfort and low back pain[3months]
Key secondary outcomes
URES[0,3months]
Wfun[3months]
Athens sleep scale[0,3months]
Occupational stress questionnaire[0,3months]
K6[0,3months]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
A system that extends the smartphone function which can easily feedback expert knowledge:3 months
Interventions/Control_2
Control
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Person who consented to research
2)Person who possesses smartphone and can install application
Key exclusion criteria
1)Those participating in other clinical trials
2)Persons with obvious disability or limitation of exercise
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ko Matsudaira |
Organization
University of Tokyo
Division name
22nd Century Medical Center
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9545
okah-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Oka |
Organization
University of Tokyo
Division name
22nd Century Medical Center
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9545
Homepage URL
okah-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Fullhapp
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2018 | Year | 09 | Month | 01 | 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
| 2018 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 26 | 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
| 2018 | Year | 08 | Month | 25 | Day |
Last modified on
| 2018 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038307
| 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 |
