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

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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

Official Title
-----------------
Quality of Life Evaluation With the SRI Questionnaire of ALS Patient With Non-invasive Ventilation

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Other: Score completion


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patient requiring NIV<br>Clinical examination, completion of the ALS-FRS score, completion of the SRI score. | Other: Score completion<br>* completion of the SRI score<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SRI of patients with total ventilatory dependence in ALS | SRI questionnaire assessment at inclusion and at 3-month follow-up | 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) | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amyotrophic lateral sclerosis, quality of life evaluation, SRI questionnaire, Zarit Burden interview