Quality of Life of Caregivers and Patients Suffering From Multiple System Atrophy (QUA2-AMS)

Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder that cause as other neurodegenerative diseases profound declines in functioning and thus, require caregiving for assistance with daily living. The aim of the study is to evaluate the effect of a multimodal intervention as proposed by the NYU Caregiver Counseling and Support Intervention (NYUCI) on the quality of life of patients and their caregivers.

Study Overview

• Status: Completed
• Conditions: Multiple System Atrophy
• Intervention / Treatment: Behavioral: Multimodal intervention

Detailed Description

Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder, which is characterized by a variable combination of parkinsonism, cerebellar dysfunction, autonomic failure, and additional signs. No effective treatment is available. MSA patients have a poor prognosis with a median survival ranging between 6 and 10 years. MSA as other neurodegenerative diseases cause profound declines in functioning ; thus, many patients require caregivers for assistance with daily living. Caregiving can also be extremely stressful, and many caregivers experience declines in mental health. All of these repercussions contribute to the deterioration of the caregiver's quality of life and they can have an impact on the patient, in particular, on the patient's survival. Improving quality of life is a major element and identifying effective targeted interventions would bring immediate and direct benefit to patients and their families. In this context, it seems that a multimodal intervention as proposed by the NYU Caregiver Counseling and Support Intervention (NYUCI) developed by Mittelman could contribute to improve disease management and better coping with daily living difficulties. The NYUCI strategy combines sessions of individual and family counseling, support group participation, and additional on-call telephone consultations in a flexible counseling approach that is tailored to each caregiving family

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33 076
    • CHU Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Patients Inclusion Criteria :

• Patients suffering from "possible" or "probable" MSA according to clinical consensus criteria
• Living at home
• Presence of at least one close person (family caregiver or not) in the entourage
• Unified Multiple System Atrophy Rating Scale (UMSARS) IV ≤4
• Written informed consent
• Patient covered by the national health system

Caregivers Inclusion Criteria :

• Age > 18
• Able to answer to study scales and survey
• Written informed consent

Patients Exclusion Criteria:

• Unified Multiple System Atrophy Rating Scale (UMSARS) IV > 4
• Absence of at least one close person

Caregivers Inclusion Criteria :

- Enable to answer to study scales and survey

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal intervention at inclusion; Multimodal intervention will be proposed to Multiple system atrophy patients and their caregivers.	Behavioral: Multimodal intervention; The intervention consists of identifying the individual needs of each caregiver and patient and identifying sources of improvement in the management of daily life, including the optimization of social support. This optimization requires the involvement of people in the environment (family, friends, neighbours) who can provide help, support of any kind, recurrent or punctual, minimizing negative family interactions and maximizing positive contributions by each in supporting and supporting the individual. The intervention is personalized in the sense that the content of each session seeks to adapt itself to the specificities of the couple situation and its surroundings. interviews/meetings involving a psychologist social worker.
Other: Multimodal intervention at 6 month; Multimodal intervention will be proposed to Multiple system atrophy patients and their caregivers.	Behavioral: Multimodal intervention; The intervention consists of identifying the individual needs of each caregiver and patient and identifying sources of improvement in the management of daily life, including the optimization of social support. This optimization requires the involvement of people in the environment (family, friends, neighbours) who can provide help, support of any kind, recurrent or punctual, minimizing negative family interactions and maximizing positive contributions by each in supporting and supporting the individual. The intervention is personalized in the sense that the content of each session seeks to adapt itself to the specificities of the couple situation and its surroundings. interviews/meetings involving a psychologist social worker.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multiple System Atrophy Quality of Life (MSA-QoL) Score	Score of emotional and social sub-dimension of the MSA Quality of Life scale. Quality of life questionnaire to collect the level of difficulty experienced by the patient (from no problem to extreme problem) during the 4 weeks preceding the interview on activities such as: moving; walking; maintaining balance; speak; feed oneself. It also assesses the patient's feelings about his illness.	Day 0
Multiple System Atrophy Quality of Life (MSA-QoL) Score	Score of emotional and social sub-dimension of the MSA Quality of Life scale. Quality of life questionnaire to collect the level of difficulty experienced by the patient (from no problem to extreme problem) during the 4 weeks preceding the interview on activities such as: moving; walking; maintaining balance; speak; feed oneself. It also assesses the patient's feelings about his illness.	6 month
Multiple System Atrophy Quality of Life (MSA-QoL) Score	Score of emotional and social sub-dimension of the MSA Quality of Life scale. Quality of life questionnaire to collect the level of difficulty experienced by the patient (from no problem to extreme problem) during the 4 weeks preceding the interview on activities such as: moving; walking; maintaining balance; speak; feed oneself. It also assesses the patient's feelings about his illness.	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Center for Epidemiologic Sutdies-Depression (CESD) Score	20 items scale used to assess the existence of a depressive syndrome. Scores less than 15 does not indicate any depressive disorder Scores between 15 and 21 are indicative of mild to moderate depression. Scores above 21 are consistent with the existence of severe/ major depression	Day 0
Center for Epidemiologic Sutdies-Depression (CESD) Score	20 items scale used to assess the existence of a depressive syndrome. Scores less than 15 does not indicate any depressive disorder Scores between 15 and 21 are indicative of mild to moderate depression. Scores above 21 are consistent with the existence of severe/ major depression	3 month
Center for Epidemiologic Sutdies-Depression (CESD) Score	20 items scale used to assess the existence of a depressive syndrome. Scores less than 15 does not indicate any depressive disorder Scores between 15 and 21 are indicative of mild to moderate depression. Scores above 21 are consistent with the existence of severe/ major depression	6 month
Multiple System Atrophy Quality of Life (MSA-QoL) Score	Score of other sub-dimension of the MSA Quality of Life scale. The MSA-QoL questionnaire is composed of three different subscales: motor (14 items), non-motor (12 items) and emotional/social (14 items). The response options for each question range from 0 (no problem) to 4 (extreme problem) with higher total scores reflecting more impaired quality of life. The MSA-QoL also includes a visual analogue scale (VAS) of how satisfied patients feel (range 0-100, with lower scores indicating lower quality of life).	Day 0
Multiple System Atrophy Quality of Life (MSA-QoL) Score	Score of other sub-dimension of the MSA Quality of Life scale. The MSA-QoL questionnaire is composed of three different subscales: motor (14 items), non-motor (12 items) and emotional/social (14 items). The response options for each question range from 0 (no problem) to 4 (extreme problem) with higher total scores reflecting more impaired quality of life. The MSA-QoL also includes a visual analogue scale (VAS) of how satisfied patients feel (range 0-100, with lower scores indicating lower quality of life).	3 month
Multiple System Atrophy Quality of Life (MSA-QoL) Score	Score of other sub-dimension of the MSA Quality of Life scale. The MSA-QoL questionnaire is composed of three different subscales: motor (14 items), non-motor (12 items) and emotional/social (14 items). The response options for each question range from 0 (no problem) to 4 (extreme problem) with higher total scores reflecting more impaired quality of life. The MSA-QoL also includes a visual analogue scale (VAS) of how satisfied patients feel (range 0-100, with lower scores indicating lower quality of life).	6 month
State Trait Inventory Anxiety (STAI) Score	Anxiety assessment. 2 scales of 20 questions used to assess how subjects feel at the time and generally. Score > 65 means high anxiety ; Score < 35 means low anxiety	Day 0
State Trait Inventory Anxiety (STAI) Score	Anxiety assessment. 2 scales of 20 questions used to assess how subjects feel at the time and generally. Score > 65 means high anxiety ; Score < 35 means low anxiety	3 month
State Trait Inventory Anxiety (STAI) Score	Anxiety assessment. 2 scales of 20 questions used to assess how subjects feel at the time and generally. Score > 65 means high anxiety ; Score < 35 means low anxiety	6 month
Unified Multiple System Atrophy Rating Scale (UMSARS) I	(0=no disorder, 48=severe disorders): Is an assessment of daily life activities via 12 12 items scale used to assess language, writing, autonomy , walking and the presence of possible urinary, sexual or intestinal disorders. (0=no disorder, 48=severe)	Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) I	(0=no disorder, 48=severe disorders): Is an assessment of daily life activities via 12 12 items scale used to assess language, writing, autonomy , walking and the presence of possible urinary, sexual or intestinal disorders. (0=no disorder, 48=severe)	3 month
Unified Multiple System Atrophy Rating Scale (UMSARS) I	(0=no disorder, 48=severe disorders): Is an assessment of daily life activities via 12 12 items scale used to assess language, writing, autonomy , walking and the presence of possible urinary, sexual or intestinal disorders. (0=no disorder, 48=severe)	6 month
Unified Multiple System Atrophy Rating Scale (UMSARS) II	Motor examination based on 14 items that allow to evaluate in particular facial expression, oculomotricity, oral expression, tremors or walking. 0=no disorder, 56=severe disorders	Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) II	Motor examination based on 14 items that allow to evaluate in particular facial expression, oculomotricity, oral expression, tremors or walking. 0=no disorder, 56=severe disorders	3 month
Unified Multiple System Atrophy Rating Scale (UMSARS) II	Motor examination based on 14 items that allow to evaluate in particular facial expression, oculomotricity, oral expression, tremors or walking. 0=no disorder, 56=severe disorders	6 month
Unified Multiple System Atrophy Rating Scale (UMSARS) III	Blood pressure and heart rate measurements in the lying and standing position for 10 min every minute.	Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) III	Blood pressure and heart rate measurements in the lying and standing position for 10 min every minute.	3 month
Unified Multiple System Atrophy Rating Scale (UMSARS) III	Blood pressure and heart rate measurements in the lying and standing position for 10 min every minute.	6 month
Unified Multiple System Atrophy Rating Scale (UMSARS) IV	Assessment of the disability from 1 to 5. 1 = completely independent ; 5 = totally dependent	Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) IV	Assessment of the disability from 1 to 5. 1 = completely independent ; 5 = totally dependent	3 month
Unified Multiple System Atrophy Rating Scale (UMSARS) IV	Assessment of the disability from 1 to 5. 1 = completely independent ; 5 = totally dependent	6 month
Montreal Cognitive Assessment (MoCA) Score	evaluates short-term memory, visuospatial skills, executive functions, attention, concentration, work memory, language, abstraction, computation, and time and space orientation. Cognitive impairment is assessed by the score on 30 points (27-30: no cognitive impairment; 21-26: mild).	Day 0
Montreal Cognitive Assessment (MoCA) Score	evaluates short-term memory, visuospatial skills, executive functions, attention, concentration, work memory, language, abstraction, computation, and time and space orientation. Cognitive impairment is assessed by the score on 30 points (27-30: no cognitive impairment; 21-26: mild).	3 month
Montreal Cognitive Assessment (MoCA) Score	evaluates short-term memory, visuospatial skills, executive functions, attention, concentration, work memory, language, abstraction, computation, and time and space orientation. Cognitive impairment is assessed by the score on 30 points (27-30: no cognitive impairment; 21-26: mild).	6 month
Zarit Scale score	Assesses caregiver burden. 22 item scale with total score ranging from 0 to 88. Score 20 mean zero load - Score > 60 means severe load	Day 0
Zarit Scale score	Assesses caregiver burden. 22 item scale with total score ranging from 0 to 88. Score 20 mean zero load - Score > 60 means severe load	3 month
Zarit Scale score	Assesses caregiver burden. 22 item scale with total score ranging from 0 to 88. Score 20 mean zero load - Score > 60 means severe load	6 month
Family Relations Index (FRI)	27 items used to assess family functioning : family cohesion, verbalization of feelings and family conflict.	Day 0
Family Relations Index (FRI)	27 items used to assess family functioning : family cohesion, verbalization of feelings and family conflict.	3 month
Family Relations Index (FRI)	27 items used to assess family functioning : family cohesion, verbalization of feelings and family conflict.	6 month

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Alexandra FOUBERT-SAMIER, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): June 26, 2024
• Study Completion (Actual): July 17, 2025

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Multiple System Atrophy; Neurodegenerative disease; Multimodal intervention
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Basal Ganglia Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Multiple System Atrophy; Neurodegenerative Diseases
• Other Study ID Numbers: CHUBX 2020/29; 2020-A01962-37 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No