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Clinical Trials/NCT03641261
NCT03641261
Completed
N/A

Evaluation of the Feasibility and Effect of Therapeutic Education Sessions Using an Internet Application in Hereditary Ichthyosis

University Hospital, Toulouse1 site in 1 country42 target enrollmentOctober 29, 2018
ConditionsIchthyosis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ichthyosis
Sponsor
University Hospital, Toulouse
Enrollment
42
Locations
1
Primary Endpoint
Global use
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The main purpose is to evaluate the feasibility (global use) of a therapeutic patient education program using a specific web application in patients with hereditary ichthyosis.

Registry
clinicaltrials.gov
Start Date
October 29, 2018
End Date
February 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient with hereditary ichthyosis, according to the classification established during the 2009 consensus conference
  • Who has given his informed consent form
  • Who is affiliated to a social security system

Exclusion Criteria

  • Patient who has already participated in a therapeutic patient education program for the hereditary ichthyosis
  • Unable to connect or use a computer tool
  • Impossibility to be present at the only face-to-face session
  • Patient who is not available for the collective educational session
  • Patient with little or no motivation to follow a therapeutic patient education program (motivation evaluated by the educational team by phone call before inclusion)
  • Patient not mastering the French language
  • Person under legal protection (guardianship, curators or safeguard of justice)

Outcomes

Primary Outcomes

Global use

Time Frame: 6 months

percentage of patients who have used the "WebIchtyose" application for at least 8 hours during 6 months

Secondary Outcomes

  • Fractional use in each domain (educational sessions)(6 months)
  • Number of lost to follow-up patients(9 months)
  • Patient acceptability(6 months)
  • Educational team acceptability(6 months)
  • Coping scale(Inclusion and 6 months)
  • Fractional use in each domain (questionnaires)(6 months)
  • Difficulties of use in everyday life by the patient(6 months)
  • Response time(6 months)
  • Knowledge about disease and treatments(Inclusion and 6 months)
  • Number of relaunches(2 months, 4 months and 6 months)
  • Fractional use in each domain (continuous educational follow-up)(6 months)
  • Difficulty of individual application registration(Baseline)
  • Number of non-received questionnaires(2 months, 4 months and 6 months)
  • Attractiveness(6 months)
  • Quality of life before and after treatment(Inclusion, 6 months and 9 months)
  • Self-assessment of cutaneous severity(Inclusion and 6 months)
  • Self-care skills(Inclusion and 6 months)
  • Self-esteem(Inclusion and 6 months)
  • Fractional use in each domain (consultation)(6 months)
  • Fractional use in each domain(6 months)
  • Number of exchanges(3 months and 5 months)

Study Sites (1)

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