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Completed

NCT Number: NCT03641261

Therapeutic Education 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.

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Key information

Conditions

Ichthyosis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Keratosis Skin Abnormalities Skin Diseases Skin and Connective Tissue Diseases

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse, Hôpital Larrey

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Therapeutic patient education program

Other

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

Primary outcomes

  1. Global use

    Time frame: 6 months

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

Secondary outcomes

  1. Fractional use in each domain (educational sessions)

    Time frame: 6 months

    "WebIchtyose" application use time by the patient for group and individual educational sessions

  2. 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

  3. 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

  4. Fractional use in each domain (questionnaires)

    Time frame: 6 months

    "WebIchtyose" application use time by the patient for the filling of the questionnaires

  5. 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. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Number of non-received questionnaires

    Time frame: 2 months, 4 months and 6 months

    Number of non-received questionnaires after relaunch

  12. Number of lost to follow-up patients

    Time frame: 9 months

    Number of lost to follow-up patients

  13. Patient acceptability

    Time frame: 6 months

    Acceptability questionnaire to be completed by the patient

  14. Educational team acceptability

    Time frame: 6 months

    Acceptability questionnaire to be completed by each member of the educational team

  15. Attractiveness

    Time frame: 6 months

    Application attractiveness questionnaire completed by the patient

  16. Quality of life before and after treatment

    Time frame: Inclusion, 6 months and 9 months

    Quality of life questionnaire for hereditary ichthyosis (IQoL-32)

  17. 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

  18. Knowledge about disease and treatments

    Time frame: Inclusion and 6 months

    Questionnaire of knowledge about disease and treatments

  19. Self-care skills

    Time frame: Inclusion and 6 months

    Questionnaire of self-care skills

  20. 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.

  21. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: e-ETPichtyose

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2018
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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