Study Purpose:
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 NIVThis study also seeks to assess the quality of life of the caregivers with the Zarit Burden interview in those two populations
Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
Score completion
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Capucine Pr MORELOT PANZINI, MD PhD, APHP
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Capucine Pr MORELOT PANZINI, MD PhD / email hidden; JavaScript is required / +33 1 42 16 77 71
Full Study Summary:
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
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 Sponsor:
Assistance Publique - Hôpitaux de Paris
Estimated Enrollment:
44
Estimated Study Start Date:
09 / 13 / 2022
Estimated Study Completion Date:
09 / 13 / 2024
Posting Last Modified Date:
09 / 19 / 2022
Date Study Added to neals.org:
08 / 12 / 2022
Minimum Age:
18 Years
Maximum Age:
N/A
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
Pneumology departement, Pitié-Salpêtrière hospital, GHU APHP-Sorbonne Université | Recruiting
Capucine Pr MORELOT-PANZINI, MD PhD / 01 42 16 78 59 Ext. +33 / email hidden; JavaScript is required
Paris 75013
France