MYLIFE: Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04731493
Collaborator
(none)
60
1
37.9
1.6

Study Details

Study Description

Brief Summary

This is a before-after, observational, prospective, multicenter cohort study. The study will consist of 2 phases: an initial observational phase of a minimum of 3 months before the Therapeutic Education Program (TEP) intervention, then a phase of evolution analysis of at least 3 months.

Condition or Disease Intervention/Treatment Phase
  • Other: Therapeutic Education Program

Detailed Description

During the first observational phase, the quality of life assessment will be carried out 3 months apart without intervention. The data obtained during this first phase will make it possible to characterize the functional impact in patients, to verify the reproducibility of our evaluations, and to evaluate the spontaneous evolution of the parameters over a period of 3 months.

During the second phase of evolution analysis, the quality of life will be assessed at 3 month intervals (M9, M12) after the therapeutic Education Program (M6). The comparison between the evolution during the two phases, before and after the TEP will allow us to assess the benefits of the TEP.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome: an Observational, Prospective and Multicenter Study
Actual Study Start Date :
Dec 2, 2020
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm Intervention/Treatment
therapeutic Education Program

individual and group sessions will be set up with educational workshops specialized by age group (child / adolescent / transition / adult / entourage / parents), socio-administrative workshops, etc. The objectives will be adapted to each age group and to each patient individually.

Other: Therapeutic Education Program
needs assessment educational group workshop specialized workshops by age group: child / adolescent / transition / adult / entourage / separated parents and in parallel socio-administrative workshop individual summary (accompanied or not by his entourage / family) satisfaction questionnaire

Outcome Measures

Primary Outcome Measures

  1. quality of life of children and young adults with Marfan [Base line]

    Answer to the question of PedsQL

  2. quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP), [3 months]

    Answer to the question of PedsQL

  3. quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP), [9 months]

    Answer to the question of PedsQL

  4. quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP), [12 months]

    Answer to the question of PedsQL

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 25 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patient aged between 7 and 25 years old with Marfan Syndrome or related according to Ghent criteria

  • For minors, no oral opposition from the holders of parental authority and consent of the minor.

  • For adults, no oral opposition collected

  • Patient affiliated to a social security scheme or equivalent

Exclusion Criteria:
  • Inability of the patient to understand the content of the TEP sessions or the questionnaire about quality of life (non-French speaking, severe intellectual disability)

  • Patient who has already participated in a TEP session for his pathology.

  • Protected adult: patient under legal guardianship or curator protection

Contacts and Locations

Locations

Site City State Country Postal Code
1 UHToulouse Toulouse France 31000

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Yves DULAC, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT04731493
Other Study ID Numbers:
  • RC31/19/0505
First Posted:
Feb 1, 2021
Last Update Posted:
Feb 1, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2021