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

Amyotrophic Lateral Sclerosis Clinical Trial

— Quality EvALS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498883
• Other study ID #: APHP220697
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: September 13, 2024

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Capucine Pr MORELOT PANZINI, MD PhD
• Phone: +33 1 42 16 77 71
• Email: capucine.morelot[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 13, 2024
• Est. primary completion date: September 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• Score completion
completion of the SRI score

Locations

Country	Name	City	State
France	Pneumology departement, Pitié-Salpêtrière hospital, GHU APHP-Sorbonne Université	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	SRI of patients with total ventilatory dependence in ALS	SRI questionnaire assessment at inclusion and at 3-month follow-up	three months
Secondary	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