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

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

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Other: Score completion

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Capucine Pr MORELOT PANZINI, MD PhD; Phone Number: +33 1 42 16 77 71; Email: capucine.morelot@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Pneumology departement, Pitié-Salpêtrière hospital, GHU APHP-Sorbonne Université
    • Contact: Capucine Pr MORELOT-PANZINI, MD PhD; Phone Number: +33 01 42 16 78 59; Email: capucine.morelot@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Capucine Pr MORELOT PANZINI, MD PhD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Estimated): September 13, 2024
• Study Completion (Estimated): September 13, 2024

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: amyotrophic lateral sclerosis; quality of life evaluation; SRI questionnaire; Zarit Burden interview
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: APHP220697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No