UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037900 |
|---|---|
| Receipt number | R000043202 |
| Scientific Title | Study to clarify the relationship between joint conditions and sensing data acquired by smartphones and wearable devices |
| Date of disclosure of the study information | 2019/09/04 |
| Last modified on | 2020/06/22 06:50:06 |
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Basic information
Public title
Study to clarify the relationship between joint conditions and sensing data acquired by smartphones and wearable devices
Acronym
Study to clarify the relationship between joint conditions and sensing data acquired by smartphones and wearable devices
Scientific Title
Study to clarify the relationship between joint conditions and sensing data acquired by smartphones and wearable devices
Scientific Title:Acronym
Study to clarify the relationship between joint conditions and sensing data acquired by smartphones and wearable devices
Region
| Japan |
Condition
Condition
joint pain and/or swelling
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of the study are to clarify the relationship between joint conditions and sensing data obtained by smartphones and wearable devices, and to develop machine learning models to estimate the degree of joint conditions from the sensing data.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between joint conditions and sensing data obtained by smartphones and wearable devices
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
Patients at age 20 or over with joint pain and/or swelling who visit Keio University Hospital or Tokyo Medical Center
Key exclusion criteria
-When the patient or his / her family cannot operate the smartphone
-A patient who suffers from a disease that may affect the acquisition of biometric information due to any physical disease. For example, those with diseases that affect measurement with wearable devices (people with limb paralysis or involuntary movements, etc.)
-Other patients who are deemed inappropriate by the research director
-Those who do not agree to participate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Izumi |
Organization
National Tokyo Medical Center
Division name
Division of Connective Tissue Diseases
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
visualizepain@gmail.com
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Izumi |
Organization
National Tokyo Medical Center
Division name
Division of Connective Tissue Diseases
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
Homepage URL
visualizepain@gmail.com
Sponsor or person
Institute
National Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Tokyo Medical Center, Keio University School of Medicine, etc.
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
The Clinical and Translational Research Center
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
Tel
03-3411-0111
med-rinri-jimu@mail.hosp.go.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
東京医療センター(東京都)
慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 04 | 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
| 2019 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A)Collection of background factors
Obtain the following information from the electronic medical record:
-Sex, age, disease with joint symptoms, disease duration, symptoms and physical examination information, test data related to the disease, X-ray images, presence of other diseases affecting physical activity and its disease activity, smoking history, drugs used, etc.
B)Sensing data collection by sensing devices
Researchers lend smartphones and wearable devices and patients will wear them for a maximum of 7 months. The sensing devices are connected to the researcher's PC with a USB cable at an outpatient or ward at regular intervals.
-Smartphones
Apple's iPhones are used to obtain step count data and barometric pressure data recorded by default in the iPhone.
-Wearable devices
Either of Fitbit devices or Apple Watch is used to acquire acceleration data such as body movements and sensing data including heart rates.
C)Recording joint conditions
The subjective symptoms of joints, self-evaluation of physical function, and pain / swelling records of joints are answered with the app and recorded in the smartphone.
In addition, when patients see a doctor, patients can record general evaluation (G-VAS), tender joints, swollen joints, etc. by physicians in the app of the smartphone.
Management information
Registered date
| 2019 | Year | 09 | Month | 02 | Day |
Last modified on
| 2020 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043202
| 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 |
