Ichthyosise-ETPichtyoseNCT03641261
Therapeutic Education Using an Internet Application in Hereditary Ichthyosis
A study testing Therapeutic patient education program in people with Ichthyosis, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Ichthyosis
- What is being tested?
- Therapeutic patient education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 29 Oct 2018to 21 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ichthyosis
- Being tested
- Therapeutic patient education program
- Keywords
- Hereditary ichthyosis
- Medical subject headings
- Ichthyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic patient education programOther
Also called WebIchtyose
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
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Patient Education program | Experimental | All included patients will follow a Therapeutic Patient Education program dedicated to the hereditary ichthyosis and using a web application, WebIchtyose Receives: Other: Therapeutic patient education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global use
percentage of patients who have used the "WebIchtyose" application for at least 8 hours during 6 months
Measured: 6 months
Secondary outcomes (21)
Fractional use in each domain (educational sessions)
"WebIchtyose" application use time by the patient for group and individual educational sessions
Measured: 6 months
Fractional use in each domain (continuous educational follow-up)
"WebIchtyose" application use time by the patient for the continuous educational follow-up
Measured: 6 months
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
Measured: 6 months
Fractional use in each domain (questionnaires)
"WebIchtyose" application use time by the patient for the filling of the questionnaires
Measured: 6 months
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
Measured: 6 months
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
Measured: Baseline
Difficulties of use in everyday life by the patient
Questionnaire completed for each patient jointly by the patient at the end of the program
Measured: 6 months
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
Measured: 3 months and 5 months
Response time
Response time of the educational team following a request from the patient as part of the educational follow-up
Measured: 6 months
Number of relaunches
How many times the nurse relaunches the patient to obtain the assessment questionnaires
Measured: 2 months, 4 months and 6 months
Number of non-received questionnaires
Number of non-received questionnaires after relaunch
Measured: 2 months, 4 months and 6 months
Number of lost to follow-up patients
Number of lost to follow-up patients
Measured: 9 months
Patient acceptability
Acceptability questionnaire to be completed by the patient
Measured: 6 months
Educational team acceptability
Acceptability questionnaire to be completed by each member of the educational team
Measured: 6 months
Attractiveness
Application attractiveness questionnaire completed by the patient
Measured: 6 months
Quality of life before and after treatment
Quality of life questionnaire for hereditary ichthyosis (IQoL-32)
Measured: Inclusion, 6 months and 9 months
Self-assessment of cutaneous severity
Self-assessment of cutaneous severity according to an analogic visual scale for pain, pruritus, erythema, squama
Measured: Inclusion and 6 months
Knowledge about disease and treatments
Questionnaire of knowledge about disease and treatments
Measured: Inclusion and 6 months
Self-care skills
Questionnaire of self-care skills
Measured: Inclusion and 6 months
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.
Measured: Inclusion and 6 months
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.
Measured: Inclusion and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start29 Oct 2018
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IchthyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliette Mazereeuw-Hautier, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641261
- Sponsor's protocol ID
- RC31/16/8765
- Acronym
- e-ETPichtyose
- Status last verified
- Apr 2024
- First submitted
- 4 Jun 2018
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility and Effect of Therapeutic Education Sessions Using an Internet Application in Hereditary Ichthyosis
- ClinicalTrials.gov ID
- NCT03641261
- Acronym / sponsor ID
- e-ETPichtyose / RC31/16/8765
- Conditions
- Ichthyosis
- Keywords
- Hereditary ichthyosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Patient Education program | Experimental | Other: Therapeutic patient education programAll included patients will follow a Therapeutic Patient Education program dedicated to the hereditary ichthyosis and using a web application, WebIchtyose |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic patient education programAlso: WebIchtyoseWebIchtyose 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 | Therapeutic Patient Education program |
Primary outcome
Global use
Time frame: 6 months
percentage of patients who have used the "WebIchtyose" application for at least 8 hours during 6 months
21 secondary outcomes
Fractional use in each domain (educational sessions)
Time frame: 6 months
Fractional use in each domain (continuous educational follow-up)
Time frame: 6 months
Fractional use in each domain (consultation)
Time frame: 6 months
Fractional use in each domain (questionnaires)
Time frame: 6 months
Fractional use in each domain
Time frame: 6 months
Difficulty of individual application registration
Time frame: Baseline
Difficulties of use in everyday life by the patient
Time frame: 6 months
Number of exchanges
Time frame: 3 months and 5 months
Response time
Time frame: 6 months
Number of relaunches
Time frame: 2 months, 4 months and 6 months
Number of non-received questionnaires
Time frame: 2 months, 4 months and 6 months
Number of lost to follow-up patients
Time frame: 9 months
Patient acceptability
Time frame: 6 months
Educational team acceptability
Time frame: 6 months
Attractiveness
Time frame: 6 months
Quality of life before and after treatment
Time frame: Inclusion, 6 months and 9 months
Self-assessment of cutaneous severity
Time frame: Inclusion and 6 months
Knowledge about disease and treatments
Time frame: Inclusion and 6 months
Self-care skills
Time frame: Inclusion and 6 months
Self-esteem
Time frame: Inclusion and 6 months
Coping scale
Time frame: Inclusion and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliette Mazereeuw-Hautier, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic patient education program in people with Ichthyosis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global use (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.