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Therapeutic Education for MSA Patients and Their Caregivers (ETP@MS)

Primary Purpose

Multiple System Atrophy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Therapeutic Education Program (TEP)
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple System Atrophy focused on measuring TherapeuticEducationProgram, Feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU ToulouseRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental patients

Arm Description

MSA patients included in the therapeutic education program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Recruitment rate
Rate of eligible patients successfully enrolled in the study
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.

Full Information

First Posted
April 6, 2023
Last Updated
June 27, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05819957
Brief Title
Therapeutic Education for MSA Patients and Their Caregivers
Acronym
ETP@MS
Official Title
Evaluation of a Therapeutic Education Program for Multiple System Atrophy Patients : MSA Feasibility
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy
Keywords
TherapeuticEducationProgram, Feasibility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental patients
Arm Type
Experimental
Arm Description
MSA patients included in the therapeutic education program
Intervention Type
Other
Intervention Name(s)
Therapeutic Education Program (TEP)
Intervention Description
the TEP lasts 12 months, being structured into 6 modules.
Primary Outcome Measure Information:
Title
Feasibility of the program
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Recruitment rate
Description
Rate of eligible patients successfully enrolled in the study
Time Frame
1 year
Title
Satisfaction rate
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margherita FABBRI, MD
Phone
0561772535
Ext
+33
Email
fabbri.m@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Estelle HARROCH
Phone
05 61 77 25 35
Email
harroch.e@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margherita FABBRI, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margherita FABBRI

12. IPD Sharing Statement

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Therapeutic Education for MSA Patients and Their Caregivers

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