UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029083 |
|---|---|
| Receipt number | R000033265 |
| Scientific Title | Research on the usefulness of embedded programs for portable terminals such as smartphones, aimed at grasping external conditions and skin conditions at home for patients with inflammatory skin diseases |
| Date of disclosure of the study information | 2017/09/11 |
| Last modified on | 2021/08/24 19:41:27 |
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Basic information
Public title
Research on the usefulness of embedded programs for portable terminals such as smartphones, aimed at grasping external conditions and skin conditions at home for patients with inflammatory skin diseases
Acronym
Evaluation of usefulness of embedded programs for portable terminals such as smartphones in patients with inflammatory skin diseases
Scientific Title
Research on the usefulness of embedded programs for portable terminals such as smartphones, aimed at grasping external conditions and skin conditions at home for patients with inflammatory skin diseases
Scientific Title:Acronym
Evaluation of usefulness of embedded programs for portable terminals such as smartphones in patients with inflammatory skin diseases
Region
| Japan |
Condition
Condition
Inflammatory skin diseases
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim for use in clinical application and research of a smartphone application
Basic objectives2
Others
Basic objectives -Others
In this research, it is verified whether a smartphone application (tentative name: skin diary) can be a useful tool for grasping external treatment situation of a patient with atopic dermatitis, grasping skin condition, and correlation between lifestyle and subjective symptoms . By this research, if the usefulness of the smartphone application (skin diary) is demonstrated, we can aim at full-scale use of the smartphone application for clinical application and research while taking safety and ethical considerations into consideration.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Application input status of research collaborators, questionnaire evaluation after using the application by patients
Key secondary outcomes
Evaluation of treatment situation at home atopic dermatitis patients based on application input results, evaluation of skin condition
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
Keio University Hospital Atopy outpatient clinic who does not meet the following exclusion criteria. The patient selection does not involve the treatment content or the degree of symptoms.
Key exclusion criteria
1) Those who can not use smartphone, those not accustomed to use.
2) Those who are judged to be difficult to cooperate with this research by research researcher or shared medical doctor from past hospitalization situation etc.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Amagai |
Organization
Keio University School of Medicine
Division name
department of dermatology
Zip code
160-8582
Address
35Shinano-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3823
amagai@keio.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawasaki |
Organization
Keio University School of Medicine
Division name
department of dermatology
Zip code
160-8582
Address
35 Shinano-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3823
Homepage URL
ebitamo@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine, department of dermatology
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine, department of dermatology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Physical and Chemical Research, Medical Sciences Innovation Hub Program
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
03-5363-3879
med-rinri-jimu@adst.keio.ac.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
慶應義塾大学病院皮膚科（東京）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 11 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Test collaborators will enter data for more than 4 weeks. Regarding the input period of the test cooperator, in principle, it takes more than 4 weeks, but for the applicant, it is permitted to use up to 6 months.
The test cooperator responds to the questionnaire on feeling of use at the outpatient visit during the skin diary use period.
Management information
Registered date
| 2017 | Year | 09 | Month | 11 | Day |
Last modified on
| 2021 | 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=R000033265
| 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 |
