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

NCT05498883 | Completed

• 1 other identifier: APHP220697
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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

Conditions

Amyotrophic Lateral Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• SRI of patients with total ventilatory dependence in ALS

  three months

• Zarit burden interview in both groups

  Six months

Study Arms (1)

patient requiring NIV

OTHER

Clinical examination, completion of the ALS-FRS score, completion of the SRI score.

Other: Score completion

Interventions

Score completion OTHER

completion of the SRI score

patient requiring NIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients :
• 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 :
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, Paris, 75013, France

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Capucine Pr MORELOT PANZINI, MD PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 12, 2022
• Study Start: September 13, 2022
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)