Multiple System AtrophyETP@MSNCT05819957
Therapeutic Education for Multiple System Atrophy (MSA) Patients and Their Caregivers
A study testing Therapeutic Education Program (TEP) in people with Multiple System Atrophy, run by University Hospital, Toulouse at 1 site in France.
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... Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- Therapeutic Education Program (TEP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2023to 10 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Therapeutic Education Program for Multiple System Atrophy (MSA) Patients : MSA Feasibility
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.
Read the detailed 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).
- Conditions
- Multiple System Atrophy
- Being tested
- Therapeutic Education Program (TEP)
- Keywords
- TherapeuticEducationProgram, Feasibility
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Education Program (TEP)Other
the TEP lasts 12 months, being structured into 6 modules.
| Study group | Role | What they receive |
|---|---|---|
| Experimental patients | Experimental | MSA patients included in the therapeutic education program Receives: Other: Therapeutic Education Program (TEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
Recruitment rate
Rate of eligible patients successfully enrolled in the study
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start30 May 2023
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margherita FABBRI, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819957
- Sponsor's protocol ID
- RC31/22/0520
- Other IDs
- 2023-A00340-45
- Acronym
- ETP@MS
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40765498
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Therapeutic Education Program for Multiple System Atrophy (MSA) Patients : MSA Feasibility
- ClinicalTrials.gov ID
- NCT05819957
- Acronym / sponsor ID
- ETP@MS / RC31/22/0520
- Conditions
- Multiple System Atrophy
- Keywords
- TherapeuticEducationProgram, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental patients | Experimental | Other: Therapeutic Education Program (TEP)MSA patients included in the therapeutic education program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Education Program (TEP)the TEP lasts 12 months, being structured into 6 modules. | Other | Experimental patients |
Primary outcome
Feasibility of the program
Time frame: 1 year
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
2 secondary outcomes
Recruitment rate
Time frame: 1 year
Satisfaction rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 40765498Fabbri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margherita FABBRI, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Education Program (TEP) in people with Multiple System Atrophy, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the program (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05819957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.