Clinical trial NCT04965922: Quality of Life of Caregivers and Patients Suffering From Multiple System Atrophy
Official title: Quality of Life of Caregivers and Patients Suffering From Multiple System Atrophy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple System Atrophy
Keywords: Multiple System Atrophy
Quality of life
Multimodal intervention
Neurodegenerative disease
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

Eligibility 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

Primary outcomes:
measure: Multiple System Atrophy Quality of Life (MSA-QoL) Score
timeFrame: Day 0
measure: Multiple System Atrophy Quality of Life (MSA-QoL) Score
timeFrame: 6 month
measure: Multiple System Atrophy Quality of Life (MSA-QoL) Score
timeFrame: 12 month
Secondary outcomes:
measure: Center for Epidemiologic Sutdies-Depression (CESD) Score
timeFrame: Day 0
measure: Center for Epidemiologic Sutdies-Depression (CESD) Score
timeFrame: 3 month
measure: Center for Epidemiologic Sutdies-Depression (CESD) Score
timeFrame: 6 month
measure: Multiple System Atrophy Quality of Life (MSA-QoL) Score
timeFrame: Day 0
measure: Multiple System Atrophy Quality of Life (MSA-QoL) Score
timeFrame: 3 month
measure: Multiple System Atrophy Quality of Life (MSA-QoL) Score
timeFrame: 6 month
measure: State Trait Inventory Anxiety (STAI) Score
timeFrame: Day 0
measure: State Trait Inventory Anxiety (STAI) Score
timeFrame: 3 month
measure: State Trait Inventory Anxiety (STAI) Score
timeFrame: 6 month
measure: Unified Multiple System Atrophy Rating Scale (UMSARS) I
timeFrame: Day 0
measure: Unified Multiple System Atrophy Rating Scale (UMSARS) I
timeFrame: 3 month
measure: Unified Multiple System Atrophy Rating Scale (UMSARS) I
timeFrame: 6 month
measure: Unified Multiple System Atrophy Rating Scale (UMSARS) II
timeFrame: Day 0
measure: Unified Multiple System Atrophy Rating Scale (UMSARS) II
timeFrame: 3 month
measure: Unified Multiple System Atrophy Rating Scale (UMSARS) II
timeFrame: 6 month
measure: Unified Multiple System Atrophy Rating Scale (UMSARS) III
timeFrame: Day 0
measure: Unified Multiple System Atrophy Rating Scale (UMSARS) III
timeFrame: 3 month
measure: Unified Multiple System Atrophy Rating Scale (UMSARS) III
timeFrame: 6 month
measure: Unified Multiple System Atrophy Rating Scale (UMSARS) IV
timeFrame: Day 0
measure: Unified Multiple System Atrophy Rating Scale (UMSARS) IV
timeFrame: 3 month
measure: Unified Multiple System Atrophy Rating Scale (UMSARS) IV
timeFrame: 6 month
measure: Montreal Cognitive Assessment (MoCA) Score
timeFrame: Day 0
measure: Montreal Cognitive Assessment (MoCA) Score
timeFrame: 3 month
measure: Montreal Cognitive Assessment (MoCA) Score
timeFrame: 6 month
measure: Zarit Scale score
timeFrame: Day 0
measure: Zarit Scale score
timeFrame: 3 month
measure: Zarit Scale score
timeFrame: 6 month
measure: Family Relations Index (FRI)
timeFrame: Day 0
measure: Family Relations Index (FRI)
timeFrame: 3 month
measure: Family Relations Index (FRI)
timeFrame: 6 month
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Alexandra FOUBERT-SAMIER
role: PRINCIPAL_INVESTIGATOR
References: