Quality of Life Evaluation with the SRI Questionnaire of ALS Patient with Non-invasive Ventilation

Assistance Publique - Hôpitaux de Paris93 enrolled

Overview

This study aims to measure the quality of life of ALS patients by the SRI questionnaire, in two distinct patient groups : Patient requiring initiation of NIV, and patients 24 hours dependent on NIV This study also seeks to assess the quality of life of the caregivers with the Zarit Burden interview in those two populations

The course of the study is as follows: Patient newly ventilated with NIV : inclusion is done on the day of starting NIV. On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score. For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month and six-month follow-up Patient dependent of NIV : On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score. For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month follow-up

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Score completionOTHER

completion of the SRI score

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients : * 18 years or more * Patient followed for ALS probable or certain with Awaji criteria * group 1 : severe chronic respiratory failure, with a decision by the attending physician to start NIV * group 2 : complete dependence on NIV Caregivers : * 18 years or more * Informed and does not object to the study * Primary caregiver for more than 3 months of an ALS patient on NIV (either at initiation or with 24 hours NIV dependence) * More than 30 hours spent at home per week * Met the inclusion criteria for group 1 (NIV initiation) or group 2 (24 hours NIV dependence) Exclusion Criteria: Patients : * Patient under legal protection/ guardianship * insufficient command of French * Severe cognitive impairment, particularly in relation to frontotemporal degeneration * No indication criteria for NIV. Caregivers : * insufficient command of French * Caregiver of a patient with another chronic pathology

Locations (1)

Pneumology departement, Pitié-Salpêtrière hospital, GHU APHP-Sorbonne Université

Paris, Paris, France

Outcomes

Primary Outcomes

SRI questionnaire in patients who have indication for starting NIV

SRI questionnaire assessment at initiation of NIV, at 3-month follow-up and at 6-month follow-up

Time frame: six months

Secondary Outcomes

SRI of patients with total ventilatory dependence in ALS

SRI questionnaire assessment at inclusion and at 3-month follow-up

Time frame: three months

Zarit burden interview in both groups

Zarit Burden interview questionnaire in ALS patient caregiver, in both groups (initiation of NIV and NIV-dependent patients) at inclusion, 3-month follow-up (both groups) and at 6-month follow-up (in group 1)

Time frame: Six months

Data from ClinicalTrials.gov

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