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Teledermatology Versus Usual Care on Delay Before Diagnosis and Treatment of Dermatologic Conditions (TELEDERMATO)

Primary Purpose

Dermatologic Conditions

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Teledermatology
Sponsored by
University Paris 7 - Denis Diderot
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dermatologic Conditions focused on measuring teledermatology, dermatology, general practice, organization of care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University paris Diderot

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Teledermatology

Usual care

Arm Description

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 and sends them to the dermatologist using a secured email server. Dermatologist answer is standardized.

Usual care for dermatologic conditions requiring an expertise from a dermatologist involves the general practitioner 1) giving the patient a paper letter containing at least the following information: date of symptoms, symptomatology, topography of lesions, description of lesions, extension, recent drug intakes) and 2) telling him to see the dermatologist of his choice (patient manages his appointments alone).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
April 22, 2014
Last Updated
June 19, 2015
Sponsor
University Paris 7 - Denis Diderot
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1. Study Identification

Unique Protocol Identification Number
NCT02122432
Brief Title
Teledermatology Versus Usual Care on Delay Before Diagnosis and Treatment of Dermatologic Conditions
Acronym
TELEDERMATO
Official Title
Impact of Teledermatology Versus Usual Care on Delay Before Diagnosis and/or Treatment of Dermatologic Conditions in General Practice
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Paris 7 - Denis Diderot

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatologic Conditions
Keywords
teledermatology, dermatology, general practice, organization of care

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teledermatology
Arm Type
Experimental
Arm Description
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 and sends them to the dermatologist using a secured email server. Dermatologist answer is standardized.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care for dermatologic conditions requiring an expertise from a dermatologist involves the general practitioner 1) giving the patient a paper letter containing at least the following information: date of symptoms, symptomatology, topography of lesions, description of lesions, extension, recent drug intakes) and 2) telling him to see the dermatologist of his choice (patient manages his appointments alone).
Intervention Type
Other
Intervention Name(s)
Teledermatology
Intervention Description
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 ?
Primary Outcome Measure Information:
Title
Delay before expertise by a dermatologist
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient's satisfaction
Description
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).
Time Frame
1 month after expertise by dermatologist
Other Pre-specified Outcome Measures:
Title
Physicians satisfaction with teledermatology
Description
questionnaire at the end of the study using simple rating scales ranging from "Not satisfied" (1) to "very satisfied" (4)
Time Frame
3 months
Title
Number of non usable photographs in teledermatology group
Description
Number of non usable photographs in teledermatology group. Assessment by dermatologists who received the photograph. Reasons for non usability
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viet Thi Tran, MD
Organizational Affiliation
University paris Diderot
Official's Role
Principal Investigator
Facility Information:
Facility Name
University paris Diderot
City
Paris
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27496852
Citation
Piette E, Nougairede M, Vuong V, Crickx B, Tran VT. Impact of a store-and-forward teledermatology intervention versus usual care on delay before beginning treatment: A pragmatic cluster-randomized trial in ambulatory care. J Telemed Telecare. 2017 Sep;23(8):725-732. doi: 10.1177/1357633X16663328. Epub 2016 Aug 5.
Results Reference
derived

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Teledermatology Versus Usual Care on Delay Before Diagnosis and Treatment of Dermatologic Conditions

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