Therapeutic Education for MSA Patients and Their Caregivers

Multiple System Atrophy Clinical Trial

— ETP@MS  

Official title:

Evaluation of a Therapeutic Education Program for Multiple System Atrophy Patients : MSA Feasibility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819957
• Other study ID #: RC31/22/0520
• Secondary ID: 2023-A00340-45
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: June 2026

Study information

• Verified date: June 2023
• Source: University Hospital, Toulouse
• Contact: Margherita FABBRI, MD
• Phone: 0561772535
• Email: fabbri.m[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The announcement of MSA diagnosis may provoke a shock in patients and their relatives. Educational programs in neurodegenerative diseases, such as Parkinson's disease (PD), offer patients and caregivers structured skills in disease knowledge, expertise, and management. Those programs may result in an improvement of patients' quality of life (QoL), empowering patients and their caregivers to deal with psychosocial challenges. Additionally, it has been shown that educational programs positively impact the perceived health of PD patients without increasing medical costs. There is no educational program for MSA patients. This is the reason why we created the first therapeutic educational program (TEP) for MSA patients and caregivers, including a mix model of in person visits and online classes and virtual activities. Herein, we aim to target early MSA patients (time to diagnosis < 1 year) and their caregivers, proposing to test the feasibility of this TEP. The program will last 12 months, involving both patients and caregivers, including a mixed model of in-person visits (at baseline and 12 months) and continuous on-line activities (learning situations, questionnaires, quizzes, videos, and interactive exercises).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Patients in a period of exclusion from another study

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Shy-Drager Syndrome

Intervention

Other:
• Therapeutic Education Program (TEP)
the TEP lasts 12 months, being structured into 6 modules.

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recruitment rate	Rate of eligible patients successfully enrolled in the study	1 year
Secondary	Satisfaction rate	Satisfaction of the patients and caregivers with the program will be assessed by means of Likert scale questionnaires, stratified for different aspects of the program, including content, ease of use and format. Drop-out reasons will be recorded, to better understand the needs or the difficulties met during the TEP by patients and caregivers. As routinely done for all MSA patients followed in our Reference Centres, Unified Multiple System Atrophy Rating Scale (UMSARS) I + II will be collected at baseline and at study ending (12 months) The scale goes from 0 to 10 : 10 representing the highest satisfaction of the program.	1 year