Therapeutic Education Using an Internet Application in Hereditary Ichthyosis

Ichthyosis Clinical Trial

— e-ETPichtyose  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641261
• Other study ID #: RC31/16/8765
• Status: Completed
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: February 21, 2023

Study information

• Verified date: April 2024
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 21, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ichthyosis
• Ichthyosis, Lamellar

Intervention

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

Locations

Country	Name	City	State
France	CHU Toulouse, Hôpital Larrey	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global use	percentage of patients who have used the "WebIchtyose" application for at least 8 hours during 6 months	6 months
Secondary	Fractional use in each domain (educational sessions)	"WebIchtyose" application use time by the patient for group and individual educational sessions	6 months
Secondary	Fractional use in each domain (continuous educational follow-up)	"WebIchtyose" application use time by the patient for the continuous educational follow-up	6 months
Secondary	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
Secondary	Fractional use in each domain (questionnaires)	"WebIchtyose" application use time by the patient for the filling of the questionnaires	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Response time	Response time of the educational team following a request from the patient as part of the educational follow-up	6 months
Secondary	Number of relaunches	How many times the nurse relaunches the patient to obtain the assessment questionnaires	2 months, 4 months and 6 months
Secondary	Number of non-received questionnaires	Number of non-received questionnaires after relaunch	2 months, 4 months and 6 months
Secondary	Number of lost to follow-up patients	Number of lost to follow-up patients	9 months
Secondary	Patient acceptability	Acceptability questionnaire to be completed by the patient	6 months
Secondary	Educational team acceptability	Acceptability questionnaire to be completed by each member of the educational team	6 months
Secondary	Attractiveness	Application attractiveness questionnaire completed by the patient	6 months
Secondary	Quality of life before and after treatment	Quality of life questionnaire for hereditary ichthyosis (IQoL-32)	Inclusion, 6 months and 9 months
Secondary	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
Secondary	Knowledge about disease and treatments	Questionnaire of knowledge about disease and treatments	Inclusion and 6 months
Secondary	Self-care skills	Questionnaire of self-care skills	Inclusion and 6 months
Secondary	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
Secondary	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