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

NCT ID: NCT04965922

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2025-07-17

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.

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

Conditions

Multiple System Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Multimodal intervention at inclusion

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

Group Type: EXPERIMENTAL

Multimodal intervention

Intervention Type: 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 will be proposed to Multiple system atrophy patients and their caregivers.

Group Type: OTHER

Multimodal intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

• Enable to answer to study scales and survey

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra FOUBERT-SAMIER

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2020/29

Identifier Type: -

Identifier Source: org_study_id