Therapeutic Education Using an Internet Application in Hereditary Ichthyosis (e-ETPichtyose)

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

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.

Study Overview

• Status: Completed
• Conditions: Ichthyosis
• Intervention / Treatment: Other: Therapeutic patient education program

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juliette Mazereeuw-Hautier, MD; Phone Number: +33 05 61 77 81 41; Email: mazereeuw-hautier.j@chu-toulouse.fr
• Study Contact Backup: Name: Isabelle Dreyfus, PharmD; Phone Number: +33 05 67 77 81 10; Email: dreyfus.i@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • CHU Toulouse, Hôpital Larrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic Patient Education program; All included patients will follow a Therapeutic Patient Education program dedicated to the hereditary ichthyosis and using a web application, WebIchtyose	Other: Therapeutic patient education program; WebIchtyose is a specific therapeutic patient education program for patients with hereditary Ichthyosis targeting the problems of each patient by means of a personalized follow-up and a constant interaction between the patient and the educational team; Other Names: WebIchtyose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global use	percentage of patients who have used the "WebIchtyose" application for at least 8 hours during 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fractional use in each domain (educational sessions)	"WebIchtyose" application use time by the patient for group and individual educational sessions	6 months
Fractional use in each domain (continuous educational follow-up)	"WebIchtyose" application use time by the patient for the continuous educational follow-up	6 months
Fractional use in each domain (consultation)	"WebIchtyose" application use time by the patient for the consultation of the "Frequently Asked Questions" area and of patient information documents made available on the application	6 months
Fractional use in each domain (questionnaires)	"WebIchtyose" application use time by the patient for the filling of the questionnaires	6 months
Fractional use in each domain	"WebIchtyose" application use time by the patient for group and individual educational sessions, the continuous educational follow-up, the consultation of the "Frequently Asked Questions" area and of patient information documents made available on the application	6 months
Difficulty of individual application registration	Difficulty of registration questionnaire completed for each patient jointly by the patient and the educational team at the end of the face-to-face inclusion visit	Baseline
Difficulties of use in everyday life by the patient	Questionnaire completed for each patient jointly by the patient at the end of the program	6 months
Number of exchanges	Number of exchanges necessary between the educational team and the patient to set a date for the conduct of the individual educational sessions	3 months and 5 months
Response time	Response time of the educational team following a request from the patient as part of the educational follow-up	6 months
Number of relaunches	How many times the nurse relaunches the patient to obtain the assessment questionnaires	2 months, 4 months and 6 months
Number of non-received questionnaires	Number of non-received questionnaires after relaunch	2 months, 4 months and 6 months
Number of lost to follow-up patients	Number of lost to follow-up patients	9 months
Patient acceptability	Acceptability questionnaire to be completed by the patient	6 months
Educational team acceptability	Acceptability questionnaire to be completed by each member of the educational team	6 months
Attractiveness	Application attractiveness questionnaire completed by the patient	6 months
Quality of life before and after treatment	Quality of life questionnaire for hereditary ichthyosis (IQoL-32)	Inclusion, 6 months and 9 months
Self-assessment of cutaneous severity	Self-assessment of cutaneous severity according to an analogic visual scale for pain, pruritus, erythema, squama	Inclusion and 6 months
Knowledge about disease and treatments	Questionnaire of knowledge about disease and treatments	Inclusion and 6 months
Self-care skills	Questionnaire of self-care skills	Inclusion and 6 months
Self-esteem	Questionnaire about self-esteem: Rosenberg scale. For each item of the questionnaire, the modality answers are : 1 (totally disagree), 2 (quite disagree), 3 (quite agree) and 4 (totally disagree). The total score (/ 40) is calculated by adding the scores obtained for each item.	Inclusion and 6 months
Coping scale	Coping with health injuries and problem (Endler 1998). For each item of the questionnaire, the modality answers are: 1 (not at all), 2 (a little), 3 (moderately), 4 (often) and 5 (a lot).The total score (/ 160) is calculated by adding the scores obtained for each item.	Inclusion and 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Juliette Mazereeuw-Hautier, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Actual): February 21, 2023
• Study Completion (Actual): February 21, 2023

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hereditary ichthyosis
• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Abnormalities; Keratosis; Ichthyosiform Erythroderma, Congenital; Ichthyosis; Ichthyosis, Lamellar
• Other Study ID Numbers: RC31/16/8765

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No