UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020873 |
|---|---|
| Receipt number | 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 | 2022/08/11 02:04:37 |
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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
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
yotsurie@hotmail.com
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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:
During the school and community skin surveys between 2015-2021, patients with severe skin diseases were enrolled to the teledermatology system. At clinics, patients with skin diseases/wounds were enrolled.
Adzope: 986 schoolchildren screened
Gagnoa: 4068 schoolchildren screened
Oume: 164 patients with skin diseases/wounds enrolled and being followed up.
Results date posted
| 2021 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Travel restrictions due to COVID-19.
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
| 2024 | 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
| 2022 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.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 |
