Multiple System Atrophy
Conditions
Keywords
TherapeuticEducationProgram, Feasibility
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.
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).
Interventions
OTHERTherapeutic Education Program (TEP)
the TEP lasts 12 months, being structured into 6 modules.
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the program | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 1 year | Rate of eligible patients successfully enrolled in the study |
| Satisfaction rate | 1 year | 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMargherita FABBRI, MD
University Hospital, Toulouse
Outcome results
None listed