NCT02465476

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 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

January 6, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

3.4 years

First QC Date

April 24, 2015

Last Update Submit

November 19, 2018

Conditions

Keywords

skin diseasetelemedicine

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (4)

  • Improvement of the treatment pathway and its organization

    6 months

  • Satisfaction of the patient

    6 months

  • Change of the cost related to the patient care (direct and indirect).

    6 months

  • management of time by the medical personal.

    6 months

Study Arms (2)

normal care

NO INTERVENTION

patient who will have normal treatment pathway

telemedicine

EXPERIMENTAL

patient who will have telemedicine

Procedure: telemedicine

Interventions

telemedicinePROCEDURE

treatment pathway organized by telemedicine

telemedicine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHToulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Skin Diseases

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Juliette Mazereeuw-Hautier, MD . PHD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2015

First Posted

June 8, 2015

Study Start

January 6, 2015

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Locations