NCT05819957

Brief Summary

Multiple system atrophy (MSA) is a rare neurodegenerative disorder that leads to major disability, forcing patients and caregivers to adapt their environment and lifestyle. Once they receive the diagnosis, patients and caregivers need to understand the symptoms, cope with them, to digest the diagnosis... All these needs are not completely addressed by the current model of care so we created a therapeutic educational program (TEP) program that will last 12 months, involving both patients and caregivers, including a mixed model of in-person visits and continuous on-line activities. Our project aims to target early MSA patients and their caregivers, proposing to test the feasibility (primary objective) of an innovative therapeutic educational program (TEP) for MSA patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 6, 2023

Last Update Submit

April 29, 2026

Conditions

Multiple System Atrophy

Keywords

TherapeuticEducationProgramFeasibility

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the program

    Rate of the patient/caregiver pairs having reached the visit at 6 months and the visit at 12 months of the ETP program. The threshold value of the rate being 80% = " retention rate ". Thus, if the rate is equal or above 80% : the program is considered feasable

    1 year

Secondary Outcomes (2)

  • Recruitment rate

    1 year

  • Satisfaction rate

    1 year

Study Arms (1)

Experimental patients

EXPERIMENTAL

MSA patients included in the therapeutic education program

Other: Therapeutic Education Program (TEP)

Interventions

Therapeutic Education Program (TEP)OTHER

the TEP lasts 12 months, being structured into 6 modules.

Experimental patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have had a clinically probable diagnosis of MSA within the last 3 years or clinically established within the last year
  • Presence of a caregiver defined as a spouse, son/daughter or relative who lives with or sees the patient on a regular basis, i.e. at least three times a week.

You may not qualify if:

  • Patients and/or caregiver unable to give consent
  • Patients without access to an internet network or without the material means to access the distance learning modules
  • Patients with a life expectancy of less than one year
  • Patients with legal guardians, curators, or legal protection
  • Patients not affiliated to a social security system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

Related Publications (1)

  • Fabbri M, Harroch E, Camgrand E, Bastos PAD, Meissner WG, Llorca MC, Travere C, Kermorgant M, Rascol O, Leung C, Roy A, Pavy-Le-Traon A, Mohara C, Scotto D'Apollonia C, Bendetowicz D, Foubert-Samier A, Brefel-Courbon C. Development and Feasibility of a Mixed Virtual and in-Presence Therapeutic Education Program for Early Multiple System Atrophy Patients. Mov Disord Clin Pract. 2025 Nov;12(11):1900-1908. doi: 10.1002/mdc3.70283. Epub 2025 Aug 6.

    PMID: 40765498RESULT

MeSH Terms

Conditions

Multiple System Atrophy

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Margherita FABBRI, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 19, 2023

Study Start

May 30, 2023

Primary Completion

February 10, 2025

Study Completion

February 10, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

FR(1)