Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-31 @ 5:24 PM
Study NCT ID:
NCT04731493
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2020-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome: an Observational, Prospective and Multicenter Study
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MYLIFE
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: