UMIN-CTR Clinical Trial

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
Email	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
Email	visualizepain@gmail.com

Sponsor
Institute	National Tokyo Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043202