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Feasibility and Effect of Therapeutic Education Sessions Using an Internet Application in Hereditary Ichtyosis (e-ETPichtyose)

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ClinicalTrials.gov Identifier: NCT03641261
Recruitment Status : Not yet recruiting
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Ichthyosis Other: Therapeutic patient education program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Feasibility and Effect of Therapeutic Education Sessions Using an Internet Application in Hereditary Ichtyosis
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : October 2019


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 Name: WebIchtyose




Primary Outcome Measures :
  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 Outcome Measures :
  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 [ 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.



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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 affilited 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, curatorship or safeguard of justice)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641261


Contacts
Contact: Juliette Mazereeuw-Hautier, MD 05 61 77 81 41 ext +33 mazereeuw-hautier.j@chu-toulouse.fr
Contact: Aude MAZA, MD 05 61 77 14 23 ext +33 maza.a@chu-toulouse.fr

Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Juliette Mazereeuw-Hautier, MD University Hospital, Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03641261     History of Changes
Other Study ID Numbers: RC31/16/8765
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Hereditary ichthyosis

Additional relevant MeSH terms:
Ichthyosis
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Keratosis
Skin Diseases