Clinical trial NCT05498883: Quality of Life Evaluation with the SRI Questionnaire of ALS Patient with Non-invasive Ventilation
Official title: Quality of Life Evaluation with the SRI Questionnaire of ALS Patient with Non-invasive Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis
quality of life evaluation
SRI questionnaire
Zarit Burden interview
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: SRI questionnaire in patients who have indication for starting NIV
timeFrame: six months
Secondary outcomes:
measure: SRI of patients with total ventilatory dependence in ALS
timeFrame: three months
measure: Zarit burden interview in both groups
timeFrame: Six months
Other outcomes:
Locations:
city: Paris
country: France
facility: Pneumology departement, Pitié-Salpêtrière hospital, GHU APHP-Sorbonne Université
Study officials:
affiliation: APHP
name: Capucine Pr MORELOT PANZINI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: