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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020873
Receipt No. R000023832
Scientific Title Development of Teledermatology System for the Globalization of NCGM
Date of disclosure of the study information 2016/02/04
Last modified on 2019/08/12

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Basic information
Public title Development of Teledermatology System for the Globalization of NCGM
Acronym NCGM-Teledermatology
Scientific Title Development of Teledermatology System for the Globalization of NCGM
Scientific Title:Acronym NCGM-Teledermatology
Region
Japan Africa

Condition
Condition Skin infections
Classification by specialty
Infectious disease Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To understand the spectrum of skin diseases in travelers visiting the traveller's clinic of the National Center for Global Health and Medicine (NCGM)
2. To develop a smartphone application software and analysis software which will be applicable to a broad setting including low- and middle-income countries.
3. To assess the efficacy of the smartphone application software as compared to the conventional face-to-face consultation.
4. To establish a tele dermatology system to connect physicians / health workers within and outside NCGM.
5. To apply the tele dermatology system in a school-based skin survey project in Cote d'Ivoire.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Diagnosis accuracy rate
Key secondary outcomes Treatment period
Disability prevalence rate

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Use of tele dermatology app in diagnosing skin diseases
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with skin symptoms who visited the traveller's clinic of the National Center for Global Health and Medicine will be included in the study. Patients under the age of 18 will need a consent form of a legal guardian.
Key exclusion criteria Patient who has already started on a treatment at different hospital or with self-judgement will be excluded.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Rie
Middle name Roselyne
Last name Yotsu
Organization National Center for Global Health and Medicine
Nagasaki University
Division name Department of Dermatology; School of Tropical Medicine and Global Health
Zip code 162-8655
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo JAPAN
TEL +81-3-3202-7181
Email yotsurie@hotmail.com

Public contact
Name of contact person
1st name Rie
Middle name Roselyne
Last name Yotsu
Organization National Center for Global Health and Medicine
Division name Department of Dermatology
Zip code 162-8655
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo JAPAN
TEL +81-3-3202-7181
Homepage URL
Email yotsurie@hotmail.com

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Leprosy Control Programme, Ministry of Health Cote d'Ivoire
Pasteur Institute
MAP International
Name of secondary funder(s) Sasakawa Health Foundation

IRB Contact (For public release)
Organization National Center for Global Health and Medicine
Address 1-21-1, Toyama, Shinjyuku-ku, Tokyo
Tel +81-3-3202-7181
Email rinrijm@hosp.ncgm.go.jp

Secondary IDs
Secondary IDs YES
Study ID_1 078-19/MSHP/CNESVS-kp
Org. issuing International ID_1 Le Comite National d'Ethique et de la Recherche, Cote d'Ivoire
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立国際医療研究センター病院 (東京都)
MAP International (コートジボワール)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
NCGM Teledermatology: A total of 23 patients have been recruited.

NCGM-Cote d'Ivoire Teledermatology: 
1. 2015: A total of 986 schoolchildren in Adzope. End-of-analysis.

2. 2016: 2,664 schoolchildren in Gagnoa were consulted for their skin symptoms and photo data was taken using smart phones (Gagnoa - 48 with photo data). Under analysis.

3. 2017: 1,394 community members in Gagnoa were consulted for their skin symptoms and photo data was taken using smart phones . Under analysis.

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
2014 Year 10 Month 01 Day
Date of IRB
2014 Year 10 Month 01 Day
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
2022 Year 03 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
2016 Year 02 Month 04 Day
Last modified on
2019 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023832

Research Plan
Registered date File name
2018/08/23 2. rinrisinsei_v2.5_四津_2018.1月訂正版_20180405.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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