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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02122432
Other study ID # DMG002
Secondary ID
Status Completed
Phase N/A
First received April 22, 2014
Last updated June 19, 2015
Start date April 2014
Est. completion date January 2015

Study information

Verified date June 2015
Source University Paris 7 - Denis Diderot
Contact n/a
Is FDA regulated No
Health authority France: Ministry of HealthFrance: Ministère de l'Enseignement supérieur et de la Recherche
Study type Interventional

Clinical Trial Summary

In France, there is usually a long delay (approximately 6 weeks) before a general practitioner can obtain a specialized advice by dermatologists for diagnosis of "unusual" dermatologic conditions of their patients.

Previous studies have shown that teledermatology is a reliable way for diagnosis in dermatology.

We hypothesize that a teledermatology advice could reduce delay before diagnosis and therefore treatment for patients.


Description:

In France, there is usually a long delay (approximately 6 weeks) before a general practitioner can obtain a specialized advice by dermatologists for diagnosis of "unusual" dermatologic conditions of their patients.

Previous studies have shown that teledermatology is a reliable way for diagnosis in dermatology.

We hypothesize that a teledermatology advice could reduce delay before diagnosis and therefore treatment for patients.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Consultation with a general practitioner for any motive during which, the general practitioner deems necessary to obtain a dermatologic expertise for a skin lesion (for diagnosis or treatment)

Exclusion Criteria:

- Emergency, assessed by the general practitioner (needs care or quick telephonic advice in the next 24 hours)

- Patients for which diagnosis and/or treatment are known by the general practitioner (the GP needs a dermatologic advice for a specific treatment (for example= laser, instrumental treatment...))

- Patient cannot go the dermatologic consultation by himself (for example: dependant patients...)

- Cognitive or psychiatric impairment (cannot give informed consent)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Teledermatology
General practitioner takes 3 photographs per dermatologic lesion using either a telephone with a 3Mega Pixel minimum camera or a standard camera following recommendations of the practice guidelines for teledermatology (2007) of the American Telemedicine Association. Photographs are sent by email using a secured mail server with at least the following information=date of symptoms, symptomatology, topography of lesions, description of lesions, extension, recent drug intakes) Photographs are read and analyzed by a single dermatologist who gives an expert answer (diagnosis and/or treatment). Answer is sent back to the general practitioner by email (using a secured mail server). Answer contains at least the following information= are photographs usable? What is the diagnosis? If necessary, which treatment should the general practitioner begin ? If necessary, does the patient need a consultation with a dermatologist ?

Locations

Country Name City State
France University paris Diderot Paris

Sponsors (1)

Lead Sponsor Collaborator
University Paris 7 - Denis Diderot

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Physicians satisfaction with teledermatology questionnaire at the end of the study using simple rating scales ranging from "Not satisfied" (1) to "very satisfied" (4) 3 months No
Other Number of non usable photographs in teledermatology group Number of non usable photographs in teledermatology group. Assessment by dermatologists who received the photograph. Reasons for non usability 3 months No
Primary Delay before expertise by a dermatologist Delay, in days, between a patient's consultation with his general practitioner and expertise by a dermatologist (teledermatology or classic consultation) that allows either diagnostic and/or initiation of treatment.
For example: in the teledermatology group, if the specialist needs to see the patient because the photographs cannot be analyzed correctly, date of expertise is the date of the consultation with the dermatologist.
Data is censured after 3 months.
3 months No
Secondary Patient's satisfaction An investigator will call patients by telephone and assess their satisfaction with their care for the dermatologic condition using a simple rating scale with 4 items ranging from "Not satisfied" (1) to "very satisfied" (4). 1 month after expertise by dermatologist No
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