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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05498883

Acronym

Quality EvALS

Enrollment

Registered

2022-08-12

Start date

2022-09-13

Completion date

2024-07-03

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosis, quality of life evaluation, SRI questionnaire, Zarit Burden interview

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

Interventions

OTHERScore completion

completion of the SRI score

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
SRI questionnaire in patients who have indication for starting NIV	six months	SRI questionnaire assessment at initiation of NIV, at 3-month follow-up and at 6-month follow-up

Secondary

Measure	Time frame	Description
SRI of patients with total ventilatory dependence in ALS	three months	SRI questionnaire assessment at inclusion and at 3-month follow-up
Zarit burden interview in both groups	Six months	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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026