Clinical trial NCT05621213: Satisfaction of Patients With Amyotrophic Lateral Sclerosis Regarding Home Assisted Teleconsultation
Official title: Satisfaction of Patients With Amyotrophic Lateral Sclerosis Under Non-invasive Ventilation Regarding Home Assisted Teleconsultation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ALS
Charcot Disease
Lead sponsor: AGIR à Dom
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient assigned to the interventional group or to the control group if they do not wish to be followed up by teleconsultation
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Satisfaction of patients with amyotrophic lateral sclerosis under non-invasive ventilation regarding home assisted teleconsultation

Detailed description: Amyotrophic Lateral Sclerosis (ALS) is a progressive and rapidly progressing neurodegenerative disease. Depending on the degree of muscle damage, patients may suffer from reduced mobility, difficulty swallowing, speech difficulties and finally respiratory weakness. Death occurs within an average of 2-3 years and is usually due to respiratory failure. Currently there is no cure for ALS, so palliative care and symptomatic treatments are essential for the management of these patients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction of ALS patients followed by teleconsultation at home
timeFrame: Between the initial visit and the 3-month visit
Secondary outcomes:
measure: Evolution of the patient's physical functions
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: Non-inferiority of ventilatory efficiency compared to conventional management
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: Non-inferiority of ventilatory efficiency compared to conventional management
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: Non-inferiority of ventilatory efficiency compared to conventional management
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: Non-inferiority of ventilatory efficiency compared to conventional management
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: Non-inferiority of ventilatory efficiency compared to conventional management
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: Non-inferiority of ventilatory efficiency compared to conventional management
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: Non-inferiority of ventilatory efficiency compared to conventional management
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: Non-inferiority of ventilatory efficiency compared to conventional management
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: Patient satisfaction with teleconsultation itself (use and patient/doctor interaction)
timeFrame: After each teleconsultation (3-month visit and 6-month visit)
measure: The evolution of satisfaction between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit
timeFrame: Between the 3-month visit, and the 6-months visit
measure: Physician satisfaction with teleconsultation
timeFrame: After each teleconsultation (3-month visit and 6-month visit)
measure: Caregivers' satisfaction with the care of the relative
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: The feasibility of home teleconsultation for ALS patients
timeFrame: Between the initial visit, the 3-month visit, and the 6-months visit
measure: Retention of follow-up modality
timeFrame: At 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
affiliation: CHU Grenoble Alpes
name: Christel Saint-Raymond, PhD
role: PRINCIPAL_INVESTIGATOR
References: