search
Back to results

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

Primary Purpose

Ichthyosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Therapeutic patient education program
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ichthyosis focused on measuring Hereditary ichthyosis

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU Toulouse, Hôpital LarreyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic Patient Education program

Arm Description

All included patients will follow a Therapeutic Patient Education program dedicated to the hereditary ichthyosis and using a web application, WebIchtyose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fractional use in each domain (educational sessions)
"WebIchtyose" application use time by the patient for group and individual educational sessions
Fractional use in each domain (continuous educational follow-up)
"WebIchtyose" application use time by the patient for the continuous educational follow-up
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
Fractional use in each domain (questionnaires)
"WebIchtyose" application use time by the patient for the filling of the questionnaires
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
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
Difficulties of use in everyday life by the patient
Questionnaire completed for each patient jointly by the patient at the end of the program
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
Response time
Response time of the educational team following a request from the patient as part of the educational follow-up
Number of relaunches
How many times the nurse relaunches the patient to obtain the assessment questionnaires
Number of non-received questionnaires
Number of non-received questionnaires after relaunch
Number of lost to follow-up patients
Number of lost to follow-up patients
Patient acceptability
Acceptability questionnaire to be completed by the patient
Educational team acceptability
Acceptability questionnaire to be completed by each member of the educational team
Attractiveness
Application attractiveness questionnaire completed by the patient
Quality of life before and after treatment
Quality of life questionnaire for hereditary ichthyosis (IQoL-32)
Self-assessment of cutaneous severity
Self-assessment of cutaneous severity according to an analogic visual scale for pain, pruritus, erythema, squama
Knowledge about disease and treatments
Questionnaire of knowledge about disease and treatments
Self-care skills
Questionnaire of self-care skills
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.
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.

Full Information

First Posted
June 4, 2018
Last Updated
August 24, 2020
Sponsor
University Hospital, Toulouse
search

1. Study Identification

Unique Protocol Identification Number
NCT03641261
Brief Title
Therapeutic Education Using an Internet Application in Hereditary Ichthyosis
Acronym
e-ETPichtyose
Official Title
Evaluation of the Feasibility and Effect of Therapeutic Education Sessions Using an Internet Application in Hereditary Ichthyosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ichthyosis
Keywords
Hereditary ichthyosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Patient Education program
Arm Type
Experimental
Arm Description
All included patients will follow a Therapeutic Patient Education program dedicated to the hereditary ichthyosis and using a web application, WebIchtyose
Intervention Type
Other
Intervention Name(s)
Therapeutic patient education program
Other Intervention Name(s)
WebIchtyose
Intervention Description
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
Primary Outcome Measure Information:
Title
Global use
Description
percentage of patients who have used the "WebIchtyose" application for at least 8 hours during 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fractional use in each domain (educational sessions)
Description
"WebIchtyose" application use time by the patient for group and individual educational sessions
Time Frame
6 months
Title
Fractional use in each domain (continuous educational follow-up)
Description
"WebIchtyose" application use time by the patient for the continuous educational follow-up
Time Frame
6 months
Title
Fractional use in each domain (consultation)
Description
"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
Time Frame
6 months
Title
Fractional use in each domain (questionnaires)
Description
"WebIchtyose" application use time by the patient for the filling of the questionnaires
Time Frame
6 months
Title
Fractional use in each domain
Description
"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
Time Frame
6 months
Title
Difficulty of individual application registration
Description
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
Time Frame
Baseline
Title
Difficulties of use in everyday life by the patient
Description
Questionnaire completed for each patient jointly by the patient at the end of the program
Time Frame
6 months
Title
Number of exchanges
Description
Number of exchanges necessary between the educational team and the patient to set a date for the conduct of the individual educational sessions
Time Frame
3 months and 5 months
Title
Response time
Description
Response time of the educational team following a request from the patient as part of the educational follow-up
Time Frame
6 months
Title
Number of relaunches
Description
How many times the nurse relaunches the patient to obtain the assessment questionnaires
Time Frame
2 months, 4 months and 6 months
Title
Number of non-received questionnaires
Description
Number of non-received questionnaires after relaunch
Time Frame
2 months, 4 months and 6 months
Title
Number of lost to follow-up patients
Description
Number of lost to follow-up patients
Time Frame
9 months
Title
Patient acceptability
Description
Acceptability questionnaire to be completed by the patient
Time Frame
6 months
Title
Educational team acceptability
Description
Acceptability questionnaire to be completed by each member of the educational team
Time Frame
6 months
Title
Attractiveness
Description
Application attractiveness questionnaire completed by the patient
Time Frame
6 months
Title
Quality of life before and after treatment
Description
Quality of life questionnaire for hereditary ichthyosis (IQoL-32)
Time Frame
Inclusion, 6 months and 9 months
Title
Self-assessment of cutaneous severity
Description
Self-assessment of cutaneous severity according to an analogic visual scale for pain, pruritus, erythema, squama
Time Frame
Inclusion and 6 months
Title
Knowledge about disease and treatments
Description
Questionnaire of knowledge about disease and treatments
Time Frame
Inclusion and 6 months
Title
Self-care skills
Description
Questionnaire of self-care skills
Time Frame
Inclusion and 6 months
Title
Self-esteem
Description
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.
Time Frame
Inclusion and 6 months
Title
Coping scale
Description
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.
Time Frame
Inclusion and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliette Mazereeuw-Hautier, MD
Phone
05 61 77 81 41
Ext
+33
Email
mazereeuw-hautier.j@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Dreyfus, PharmD
Phone
05 67 77 81 10
Ext
+33
Email
dreyfus.i@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliette Mazereeuw-Hautier, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse, Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette Mazereeuw-Hautier, MD
Phone
05 67 77 81 41
Ext
+33
Email
mazereeuw-hautier.j@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Isabelle Dreyfus, PharmD
Phone
05 67 77 81 10
Ext
+33
Email
dreyfus.i@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Juliette Mazereeuw-Hautier, MD

12. IPD Sharing Statement

Learn more about this trial

Therapeutic Education Using an Internet Application in Hereditary Ichthyosis

We'll reach out to this number within 24 hrs