NCT02122432

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 22, 2015

Status Verified

June 1, 2015

Enrollment Period

9 months

First QC Date

April 22, 2014

Last Update Submit

June 19, 2015

Conditions

Keywords

teledermatologydermatologygeneral practiceorganization of care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Patient's satisfaction

    1 month after expertise by dermatologist

Other Outcomes (2)

  • Physicians satisfaction with teledermatology

    3 months

  • Number of non usable photographs in teledermatology group

    3 months

Study Arms (2)

Teledermatology

EXPERIMENTAL

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.

Other: Teledermatology

Usual care

NO INTERVENTION

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).

Interventions

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 ?

Teledermatology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University paris Diderot

Paris, France

Location

Related Publications (1)

  • 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.

Study Officials

  • Viet Thi Tran, MD

    University paris Diderot

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 24, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 22, 2015

Record last verified: 2015-06

Locations