Rationalization of the Treatment Pathway of Patient Suffering From Rare Skin Disease With Telemedicine (Telemalrares)

November 19, 2018 updated by: University Hospital, Toulouse
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • UHToulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: normal care
patient who will have normal treatment pathway
EXPERIMENTAL: telemedicine
patient who will have telemedicine
Procedure: telemedicine
treatment pathway organized by telemedicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of the treatment pathway and its organization
Time Frame: 6 months
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.
6 months
Satisfaction of the patient
Time Frame: 6 months
questionnaire of satisfaction Short Form-36 Health Survey (SF36)
6 months
Change of the cost related to the patient care (direct and indirect).
Time Frame: 6 months
Composite criteria with number of consultations and hospitalizations, number of visit in hospital and number of days of work and school absenteeism.
6 months
management of time by the medical personal.
Time Frame: 6 months
collection by sheets of weekly time
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Juliette Mazereeuw-Hautier, MD . PHD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 6, 2015

Primary Completion (ACTUAL)

May 30, 2018

Study Completion (ACTUAL)

May 30, 2018

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (ESTIMATE)

June 8, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/13/6901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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