UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039808 |
|---|---|
| Receipt number | R000045368 |
| Scientific Title | Research on system development for integrating medical information with life-log information of atopic dermatitis patients and applying it to medical care |
| Date of disclosure of the study information | 2020/03/15 |
| Last modified on | 2020/12/04 15:04:55 |
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Basic information
Public title
Research to establish a system to utilize life-log information of patients with atopic dermatitis for medical treatment
Acronym
Skin-diary cloud research for atopic dermatitis patients
Scientific Title
Research on system development for integrating medical information with life-log information of atopic dermatitis patients and applying it to medical care
Scientific Title:Acronym
Clinical application study of life-log information of patients with atopic dermatitis
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the smartphone application "Skin Diary Cloud", we will build a personalized analysis method for life log data, and establish a patient / medical viewer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Input history and data to Skin-diary app
Key secondary outcomes
Evaluation of usability by questionnaire after implementation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
As a rule, use the skin diary app daily for one year
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have their own smartphone and go to the atopy outpatient clinic at Keio University Hospital. The patients do not meet the following exclusion criteria. The nature of treatment and the degree of symptoms are not involved in patient selection.
Key exclusion criteria
1) Patients who cannot use smartphone.
2) Patients who are judged to be difficult to cooperate with this study by the investigator or the doctor based on past visits to the hospital.
3) Those who do not have a smartphone running on the OS that guarantees the operation of the skin diary app. (iOS11.0 or higher / Android6.0 or higher)
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Keishi |
| Middle name | |
| Last name | Tanese |
Organization
Keio University School of Medicine
Division name
Dermatology department
Zip code
1608582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
03-3353-1211
tanese@keio.jp
Public contact
Name of contact person
| 1st name | HIroshi |
| Middle name | |
| Last name | Kawasaki |
Organization
Keio University School of Medicine
Division name
Dermatology department
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
hiroshi.z5@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Cabinet Office
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi Shinjuku-ku, Tokyo
Tel
03-3353-1211
keio@esct.bvits.com
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
東京都
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 13 | Day |
Last modified on
| 2020 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045368
