Quality of Life of Caregivers and Patients Suffering From Multiple System Atrophy

NCT04965922 | Completed

• 1 other identifier: CHUBX 2020/29
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple System Atrophy

Keywords

Multiple System Atrophy; Quality of life; Multimodal intervention; Neurodegenerative disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (30)

• Center for Epidemiologic Sutdies-Depression (CESD) Score

  Day 0

• Center for Epidemiologic Sutdies-Depression (CESD) Score

  3 month

• Center for Epidemiologic Sutdies-Depression (CESD) Score

  6 month

• Multiple System Atrophy Quality of Life (MSA-QoL) Score

  Day 0

• Multiple System Atrophy Quality of Life (MSA-QoL) Score

  3 month

Study Arms (2)

Multimodal intervention at inclusion

EXPERIMENTAL

Multimodal intervention will be proposed to Multiple system atrophy patients and their caregivers.

Behavioral: Multimodal intervention

Multimodal intervention at 6 month

OTHER

Multimodal intervention will be proposed to Multiple system atrophy patients and their caregivers.

Behavioral: Multimodal intervention

Interventions

Multimodal intervention BEHAVIORAL

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.

Multimodal intervention at 6 month; Multimodal intervention at inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unified Multiple System Atrophy Rating Scale (UMSARS) IV \> 4
• Absence of at least one close person
• \- Enable to answer to study scales and survey

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, 33 076, France

Location

MeSH Terms

Conditions

Multiple System Atrophy; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Alexandra FOUBERT-SAMIER

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: July 16, 2021
• Study Start: July 1, 2021
• Primary Completion: June 26, 2024
• Study Completion: July 17, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

FR (1)