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

NCT04731493 | Unknown

• 1 other identifier: RC31/19/0505
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Marfan Syndrome

Outcome Measures

Primary Outcomes (4)

• quality of life of children and young adults with Marfan

  Answer to the question of PedsQL

  Base line

• quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),

  Answer to the question of PedsQL

  3 months

• quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),

  Answer to the question of PedsQL

  9 months

• quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),

  Answer to the question of PedsQL

  12 months

Study Arms (1)

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

Interventions

Therapeutic Education Program OTHER

* 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

therapeutic Education Program

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Marphan Syndrom

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

UHToulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Marfan Syndrome

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yves DULAC, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: February 1, 2021
• Study Start: December 2, 2020
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)