Skin DiseaseTelemalraresNCT02465476
Rationalization of the Treatment Pathway of Patient Suffering From Rare Skin Disease With Telemedicine
A study testing telemedicine in people with Skin Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The investigators want to demonstrate that a new organization with telemedicine could rationalize the treatment pathway of patient suffering from rare skin disease. A diagnosis and a personalised treatment pathway could be performed before the consultation in the hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Disease
- What is being tested?
- telemedicine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2015to 30 May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- New patients suffering from a rare skin disease whatever pathology or age, which needs a take-over by this centre
- Or patients already take-over by the centre but lost to follow-up for more than one year
- Patients (and/or parents) who give their consents
- Patients (and/or parents) able to fill in questionnaires
Who cannot join
- Pregnant or breast-feeding women.
- Patients subject to a judicial safeguard order
- Patients who need an emergency take-over
- Patients followed by a doctor who does not have a computerized system or refuse to send data via the secured messaging
Trial locations and contacts
1 site in 1 country.
About this study
The investigators want to demonstrate that a new organization with telemedicine could rationalize the treatment pathway of patient suffering from rare skin disease. A diagnosis and a personalised treatment pathway could be performed before the consultation in the hospital.
- Conditions
- Skin Disease
- Being tested
- telemedicine
- Keywords
- skin disease, telemedicine
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemedicineProcedure or surgery
treatment pathway organized by telemedicine
| Study group | Role | What they receive |
|---|---|---|
| normal care | No intervention | patient who will have normal treatment pathway |
| telemedicine | Experimental | patient who will have telemedicine Receives: Procedure: telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospital visits
Interest of a procedure of telemedicine on the organization of the treatment pathway of patients affected by rare skin diseases in terms of change of the number of visit in hospital.
Measured: 6 months
Secondary outcomes (4)
Improvement of the treatment pathway and its organization
Traceability in the information system by composite criteria : number of completed application forms, number of meeting per month, number of meeting a month, number of patients treated a month, time dedicated to the logistical coordination (collection by sheets of weekly time) and number of new patients per month.
Measured: 6 months
Satisfaction of the patient
questionnaire of satisfaction Short Form-36 Health Survey (SF36)
Measured: 6 months
Change of the cost related to the patient care (direct and indirect).
Composite criteria with number of consultations and hospitalizations, number of visit in hospital and number of days of work and school absenteeism.
Measured: 6 months
management of time by the medical personal.
collection by sheets of weekly time
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start6 Jan 2015
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliette Mazereeuw-Hautier, MD . PHD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465476
- Sponsor's protocol ID
- RC31/13/6901
- Acronym
- Telemalrares
- Status last verified
- Nov 2018
- First submitted
- 24 Apr 2015
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationalization of the Treatment Pathway of Patient Suffering From Rare Skin Disease With Telemedicine
- ClinicalTrials.gov ID
- NCT02465476
- Acronym / sponsor ID
- Telemalrares / RC31/13/6901
- Conditions
- Skin Disease
- Keywords
- skin disease, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 Jan 2015 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 8 Jun 2015 (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.
The investigators want to demonstrate that a new organization with telemedicine could rationalize the treatment pathway of patient suffering from rare skin disease. A diagnosis and a personalised treatment pathway could be performed before the consultation in the hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal care | No intervention | –patient who will have normal treatment pathway |
| telemedicine | Experimental | Procedure: telemedicinepatient who will have telemedicine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- New patients suffering from a rare skin disease whatever pathology or age, which needs a take-over by this centre
- Or patients already take-over by the centre but lost to follow-up for more than one year
- Patients (and/or parents) who give their consents
- Patients (and/or parents) able to fill in questionnaires
Key exclusion criteria (4 listed)
- Pregnant or breast-feeding women.
- Patients subject to a judicial safeguard order
- Patients who need an emergency take-over
- Patients followed by a doctor who does not have a computerized system or refuse to send data via the secured messaging
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 |
|---|---|---|
| telemedicinetreatment pathway organized by telemedicine | Procedure or surgery | telemedicine |
Primary outcome
Number of hospital visits
Time frame: 6 months
Interest of a procedure of telemedicine on the organization of the treatment pathway of patients affected by rare skin diseases in terms of change of the number of visit in hospital.
4 secondary outcomes
Improvement of the treatment pathway and its organization
Time frame: 6 months
Satisfaction of the patient
Time frame: 6 months
Change of the cost related to the patient care (direct and indirect).
Time frame: 6 months
management of time by the medical personal.
Time frame: 6 months
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 20 Nov 2018.
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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.
Juliette Mazereeuw-Hautier, MD . PHD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telemedicine in people with Skin Disease, run by University Hospital, Toulouse 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 4 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 20 Nov 2018. 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?
Number of hospital visits (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2018.