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

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ClinicalTrials.gov Identifier: NCT03641261
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE June 4, 2018
First Posted Date  ICMJE August 21, 2018
Last Update Posted Date July 15, 2019
Actual Study Start Date  ICMJE October 29, 2018
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
Global use [ Time Frame: 6 months ]
percentage of patients who have used the "WebIchtyose" application for at least 8 hours during 6 months
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03641261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • Fractional use in each domain (educational sessions) [ Time Frame: 6 months ]
    "WebIchtyose" application use time by the patient for group and individual educational sessions
  • 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
  • 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
  • Fractional use in each domain (questionnaires) [ Time Frame: 6 months ]
    "WebIchtyose" application use time by the patient for the filling of the questionnaires
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Number of non-received questionnaires [ Time Frame: 2 months, 4 months and 6 months ]
    Number of non-received questionnaires after relaunch
  • Number of lost to follow-up patients [ Time Frame: 9 months ]
    Number of lost to follow-up patients
  • Patient acceptability [ Time Frame: 6 months ]
    Acceptability questionnaire to be completed by the patient
  • Educational team acceptability [ Time Frame: 6 months ]
    Acceptability questionnaire to be completed by each member of the educational team
  • Attractiveness [ Time Frame: 6 months ]
    Application attractiveness questionnaire completed by the patient
  • Quality of life before and after treatment [ Time Frame: Inclusion, 6 months and 9 months ]
    Quality of life questionnaire for hereditary ichthyosis (IQoL-32)
  • 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
  • Knowledge about disease and treatments [ Time Frame: Inclusion and 6 months ]
    Questionnaire of knowledge about disease and treatments
  • Self-care skills [ Time Frame: Inclusion and 6 months ]
    Questionnaire of self-care skills
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • Fractional use in each domain (educational sessions) [ Time Frame: 6 months ]
    "WebIchtyose" application use time by the patient for group and individual educational sessions
  • 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
  • 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
  • Fractional use in each domain (questionnaires) [ Time Frame: 6 months ]
    "WebIchtyose" application use time by the patient for the filling of the questionnaires
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Number of non-received questionnaires [ Time Frame: 2 months, 4 months and 6 months ]
    Number of non-received questionnaires after relaunch
  • Number of lost to follow-up patients [ Time Frame: 9 months ]
    Number of lost to follow-up patients
  • Patient acceptability [ Time Frame: 6 months ]
    Acceptability questionnaire to be completed by the patient
  • Educational team acceptability [ Time Frame: 6 months ]
    Acceptability questionnaire to be completed by each member of the educational team
  • Attractiveness [ Time Frame: 6 months ]
    Application attractiveness questionnaire completed by the patient
  • Quality of life [ Time Frame: Inclusion, 6 months and 9 months ]
    Quality of life questionnaire for hereditary ichthyosis (IQoL-32)
  • 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
  • Knowledge about disease and treatments [ Time Frame: Inclusion and 6 months ]
    Questionnaire of knowledge about disease and treatments
  • Self-care skills [ Time Frame: Inclusion and 6 months ]
    Questionnaire of self-care skills
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Education Using an Internet Application in Hereditary Ichthyosis
Official Title  ICMJE Evaluation of the Feasibility and Effect of Therapeutic Education Sessions Using an Internet Application in Hereditary Ichthyosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Ichthyosis
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Other: Therapeutic patient education program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 17, 2018)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Juliette Mazereeuw-Hautier, MD 05 61 77 81 41 ext +33 mazereeuw-hautier.j@chu-toulouse.fr
Contact: Isabelle Dreyfus, PharmD 05 67 77 81 10 ext +33 dreyfus.i@chu-toulouse.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03641261
Other Study ID Numbers  ICMJE RC31/16/8765
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juliette Mazereeuw-Hautier, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP