Study Purpose:
Satisfaction of patients with amyotrophic lateral sclerosis under non-invasive ventilation regarding home assisted teleconsultationStudy Status:
Not yet recruiting
Disease:
ALS , Charcot Disease
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
Teleconsultation assisted by a physiotherapist or nurse
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Christel Saint-Raymond, PhD, CHU Grenoble Alpes
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Céline Barra / email hidden; JavaScript is required / 0750543238
Full Study Summary:
The gold standard treatment for respiratory impairment is non-invasive ventilation (NIV). The aim of this mask ventilation is to improve gas exchange by compensating for the weakness of the respiratory muscles.
The progressive nature of ALS requires regular assessment of the patient's clinical condition and evaluation of NIV parameters. Regular medical appointments are therefore essential to ensure optimal ventilation and close surveillance of the patient. A day hospitalization or a consultation is organized every 3 or 4 months. These visits can cause significant fatigue, not only because of the difficulty patients have to move around but also because of the time spent waiting in hospital.
ALS is characterised by its severity and it requires our society to think about and implement new ways of managing the disease. Thus, e-health innovations could be an interesting potential in the remote follow-up of these patients, to reduce the burden of hospital consultations.
The hypothesis is that the patient will be more satisfied with a home assisted teleconsultation follow-up, while keeping the same quality of non-invasive nocturnal ventilatory assistance.
Study Sponsor:
AGIR à Dom
Estimated Enrollment:
40
Estimated Study Start Date:
11 / 30 / 2022
Estimated Study Completion Date:
08 / 31 / 2024
Posting Last Modified Date:
11 / 17 / 2022
Date Study Added to neals.org:
11 / 17 / 2022
Minimum Age:
18 Years
Maximum Age:
N/A
Inclusion Criteria:- Patient with a diagnosis of ALS coming for a follow-up consultation with their pneumologist
- Daily NIV compliance of more than 4 hours in the month prior to inclusion
- Living at home
- Patient with a natural caregiver
- Patient equipped with computer equipment adapted for teleconsultation (tablet, computer, telephone... with an internet connection)
- Patient able to read and understand the procedure, and able to express consent for the study protocol
- Patient, or his or her caregiver, able to sign the consent to participate by himself or herself
Exclusion Criteria:
- Patient not available or wishing to change region within 3 months of inclusion
- Patient currently participating or having participated in the month prior to inclusion in another clinical interventional research study that may have an impact on the study, this impact is left to the discretion of the investigator
- Persons referred to in articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons)
- Pregnant women (for women of childbearing age and in the absence of reliable contraception, the β-HCG (human chorionic gonadotropin) assay will be performed), parturient women, breastfeeding women,
- persons deprived of their liberty by judicial or administrative decision,
- persons under legal protection
CHU Grenoble Alpes
Christel Saint-Raymond, PhD / email hidden; JavaScript is required
Principal Investigator : Christel Saint-Raymond, PhD
Grenoble 38043
France
CHU Montpellier
François Bughin, PhD / 0499536218 Ext. +33 / email hidden; JavaScript is required
Bronia Ayoub / email hidden; JavaScript is required
Principal Investigator : François Bughin, PhD
Montpellier 34295
France