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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Score completion

About this trial

This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis focused on measuring amyotrophic lateral sclerosis, quality of life evaluation, SRI questionnaire, Zarit Burden interview

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patient requiring NIV

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

SRI of patients with total ventilatory dependence in ALS

SRI questionnaire assessment at inclusion and at 3-month follow-up

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)

Full Information

NCT ID

NCT05498883

First Posted

August 11, 2022

Last Updated

September 22, 2023

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT05498883

Brief Title

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

Acronym

Quality EvALS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 13, 2022 (Actual)

Primary Completion Date

September 13, 2024 (Anticipated)

Study Completion Date

September 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patient requiring NIV

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Score completion

Intervention Description

completion of the SRI score

Primary Outcome Measure Information:

Title

SRI questionnaire in patients who have indication for starting NIV

Description

SRI questionnaire assessment at initiation of NIV, at 3-month follow-up and at 6-month follow-up

Time Frame

six months

Secondary Outcome Measure Information:

Title

SRI of patients with total ventilatory dependence in ALS

Description

SRI questionnaire assessment at inclusion and at 3-month follow-up

Time Frame

three months

Title

Zarit burden interview in both groups

Description

Time Frame

Six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Capucine Pr MORELOT PANZINI, MD PhD

Phone

+33 1 42 16 77 71

capucine.morelot@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Capucine Pr MORELOT PANZINI, MD PhD

Organizational Affiliation

APHP

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Paris

ZIP/Postal Code

75013

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Capucine Pr MORELOT-PANZINI, MD PhD

Phone

01 42 16 78 59

Ext

+33

capucine.morelot@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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