Clinical trial NCT03641261: Therapeutic Education Using an Internet Application in Hereditary Ichthyosis
Official title: Evaluation of the Feasibility and Effect of Therapeutic Education Sessions Using an Internet Application in Hereditary Ichthyosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ichthyosis
Keywords: Hereditary ichthyosis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 42
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Global use
timeFrame: 6 months
Secondary outcomes:
measure: Fractional use in each domain (educational sessions)
timeFrame: 6 months
measure: Fractional use in each domain (continuous educational follow-up)
timeFrame: 6 months
measure: Fractional use in each domain (consultation)
timeFrame: 6 months
measure: Fractional use in each domain (questionnaires)
timeFrame: 6 months
measure: Fractional use in each domain
timeFrame: 6 months
measure: Difficulty of individual application registration
timeFrame: Baseline
measure: Difficulties of use in everyday life by the patient
timeFrame: 6 months
measure: Number of exchanges
timeFrame: 3 months and 5 months
measure: Response time
timeFrame: 6 months
measure: Number of relaunches
timeFrame: 2 months, 4 months and 6 months
measure: Number of non-received questionnaires
timeFrame: 2 months, 4 months and 6 months
measure: Number of lost to follow-up patients
timeFrame: 9 months
measure: Patient acceptability
timeFrame: 6 months
measure: Educational team acceptability
timeFrame: 6 months
measure: Attractiveness
timeFrame: 6 months
measure: Quality of life before and after treatment
timeFrame: Inclusion, 6 months and 9 months
measure: Self-assessment of cutaneous severity
timeFrame: Inclusion and 6 months
measure: Knowledge about disease and treatments
timeFrame: Inclusion and 6 months
measure: Self-care skills
timeFrame: Inclusion and 6 months
measure: Self-esteem
timeFrame: Inclusion and 6 months
measure: Coping scale
timeFrame: Inclusion and 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse, Hôpital Larrey
Study officials:
affiliation: University Hospital, Toulouse
name: Juliette Mazereeuw-Hautier, MD
role: PRINCIPAL_INVESTIGATOR
References: