Viewing Study NCT05498883



Ignite Creation Date: 2024-05-06 @ 5:57 PM
Last Modification Date: 2024-10-26 @ 2:39 PM
Study NCT ID: NCT05498883
Status: COMPLETED
Last Update Posted: 2023-09-25
First Post: 2022-08-11

Brief Title: Quality of Life Evaluation with the SRI Questionnaire of ALS Patient with Non-invasive Ventilation
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization: Assistance Publique - Hôpitaux de Paris

Study Overview

Official Title: Quality of Life Evaluation with the SRI Questionnaire of ALS Patient with Non-invasive Ventilation
Status: COMPLETED
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Quality EvALS
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None