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

Primary Purpose

Skin Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
telemedicine
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Skin Disease focused on measuring skin disease, telemedicine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UHToulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

normal care

telemedicine

Arm Description

patient who will have normal treatment pathway

patient who will have telemedicine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Satisfaction of the patient
questionnaire of satisfaction Short Form-36 Health Survey (SF36)
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.
management of time by the medical personal.
collection by sheets of weekly time

Full Information

First Posted
April 24, 2015
Last Updated
November 19, 2018
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02465476
Brief Title
Rationalization of the Treatment Pathway of Patient Suffering From Rare Skin Disease With Telemedicine
Acronym
Telemalrares
Official Title
Rationalization of the Treatment Pathway of Patient Suffering From Rare Skin Disease With Telemedicine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 6, 2015 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Disease
Keywords
skin disease, telemedicine

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
normal care
Arm Type
No Intervention
Arm Description
patient who will have normal treatment pathway
Arm Title
telemedicine
Arm Type
Experimental
Arm Description
patient who will have telemedicine
Intervention Type
Procedure
Intervention Name(s)
telemedicine
Intervention Description
treatment pathway organized by telemedicine
Primary Outcome Measure Information:
Title
Number of hospital visits
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement of the treatment pathway and its organization
Description
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.
Time Frame
6 months
Title
Satisfaction of the patient
Description
questionnaire of satisfaction Short Form-36 Health Survey (SF36)
Time Frame
6 months
Title
Change of the cost related to the patient care (direct and indirect).
Description
Composite criteria with number of consultations and hospitalizations, number of visit in hospital and number of days of work and school absenteeism.
Time Frame
6 months
Title
management of time by the medical personal.
Description
collection by sheets of weekly time
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliette Mazereeuw-Hautier, MD . PHD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHToulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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

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