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

University Hospital of Bordeaux

Status: Unknown

Conditions: Multiple System Atrophy

Treatments: Behavioral: Multimodal intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04965922

CHUBX 2020/29

Details and patient eligibility

About

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.

Full 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

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Multimodal intervention at inclusion

Experimental group

Description:

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

Treatment:

Behavioral: Multimodal intervention

Multimodal intervention at 6 month

Other group

Description:

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

Treatment:

Behavioral: Multimodal intervention