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

April 11, 2024 updated by: University Hospital, Toulouse

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Global use
Time Frame: 6 months
percentage of patients who have used the "WebIchtyose" application for at least 8 hours during 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fractional use in each domain (educational sessions)
Time Frame: 6 months
"WebIchtyose" application use time by the patient for group and individual educational sessions
6 months
Fractional use in each domain (continuous educational follow-up)
Time Frame: 6 months
"WebIchtyose" application use time by the patient for the continuous educational follow-up
6 months
Fractional use in each domain (consultation)
Time Frame: 6 months
"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)
Time Frame: 6 months
"WebIchtyose" application use time by the patient for the filling of the questionnaires
6 months
Fractional use in each domain
Time Frame: 6 months
"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
Time Frame: Baseline
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
Time Frame: 6 months
Questionnaire completed for each patient jointly by the patient at the end of the program
6 months
Number of exchanges
Time Frame: 3 months and 5 months
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
Time Frame: 6 months
Response time of the educational team following a request from the patient as part of the educational follow-up
6 months
Number of relaunches
Time Frame: 2 months, 4 months and 6 months
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
Time Frame: 2 months, 4 months and 6 months
Number of non-received questionnaires after relaunch
2 months, 4 months and 6 months
Number of lost to follow-up patients
Time Frame: 9 months
Number of lost to follow-up patients
9 months
Patient acceptability
Time Frame: 6 months
Acceptability questionnaire to be completed by the patient
6 months
Educational team acceptability
Time Frame: 6 months
Acceptability questionnaire to be completed by each member of the educational team
6 months
Attractiveness
Time Frame: 6 months
Application attractiveness questionnaire completed by the patient
6 months
Quality of life before and after treatment
Time Frame: Inclusion, 6 months and 9 months
Quality of life questionnaire for hereditary ichthyosis (IQoL-32)
Inclusion, 6 months and 9 months
Self-assessment of cutaneous severity
Time Frame: Inclusion and 6 months
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
Time Frame: Inclusion and 6 months
Questionnaire of knowledge about disease and treatments
Inclusion and 6 months
Self-care skills
Time Frame: Inclusion and 6 months
Questionnaire of self-care skills
Inclusion and 6 months
Self-esteem
Time Frame: Inclusion and 6 months
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
Time Frame: Inclusion and 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juliette Mazereeuw-Hautier, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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