Dermatologic ConditionsTELEDERMATONCT02122432
Teledermatology Versus Usual Care on Delay Before Diagnosis and Treatment of Dermatologic Conditions
A study testing Teledermatology in people with Dermatologic Conditions, run by University Paris 7 - Denis Diderot at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermatologic Conditions
- What is being tested?
- Teledermatology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Teledermatology Versus Usual Care on Delay Before Diagnosis and/or Treatment of Dermatologic Conditions in General Practice
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.
Read the 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.
- Conditions
- Dermatologic Conditions
- Being tested
- Teledermatology
- Keywords
- teledermatology, dermatology, general practice, organization of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeledermatologyOther
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 ?
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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).
Measured: 1 month after expertise by dermatologist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatologic ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Paris 7 - Denis Diderot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TRAN Viet thi, University Paris 7 - Denis Diderot
- Investigators
- Viet Thi Tran, MD, Principal investigator, University paris Diderot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122432
- Sponsor's protocol ID
- DMG002
- Acronym
- TELEDERMATO
- Status last verified
- Jun 2015
- First submitted
- 22 Apr 2014
- Last updated
- 22 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27496852
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Teledermatology Versus Usual Care on Delay Before Diagnosis and/or Treatment of Dermatologic Conditions in General Practice
- ClinicalTrials.gov ID
- NCT02122432
- Acronym / sponsor ID
- TELEDERMATO / DMG002
- Conditions
- Dermatologic Conditions
- Keywords
- teledermatology, dermatology, general practice, organization of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Paris 7 - Denis DiderotUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teledermatology | Experimental | Other: TeledermatologyGeneral 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 | 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeledermatologyGeneral 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 ? | Other | Teledermatology |
Primary outcome
Delay before expertise by a dermatologist
Time frame: 3 months
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.
1 secondary outcome
Patient's satisfaction
Time frame: 1 month after expertise by dermatologist
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
- Derived from this study: PubMed 27496852Piette 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viet Thi Tran, MD principal investigator
University paris Diderot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teledermatology in people with Dermatologic Conditions, run by University Paris 7 - Denis Diderot at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay before expertise by a dermatologist (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02122432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2015.