Satisfaction of Patients With Amyotrophic Lateral Sclerosis Under Non-invasive Ventilation Regarding Home Assisted Teleconsultation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Satisfaction of ALS patients followed by teleconsultation at home
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention
Patients who will be followed up by teleconsultation assisted by a physiotherapist or a nurse at home.
Intervention: Teleconsultation assisted by a physiotherapist or nurse (Other)
Control group
Patients not wishing to be followed up by teleconsultation but agreeing to participate in the study and the collection of questionnaires. They will follow up as usual in person (no teleconsultation).
Outcomes
Primary Outcomes
Satisfaction of ALS patients followed by teleconsultation at home
Time Frame: Between the initial visit and the 3-month visit
Evolution of the overall satisfaction score obtained from the Client Satisfaction Questionnaire CSQ-8, with 8 items, score 8-32. The higher the score, the more satisfied the patient is.
Secondary Outcomes
- Patient satisfaction with teleconsultation itself (use and patient/doctor interaction)(After each teleconsultation (3-month visit and 6-month visit))
- Caregivers' satisfaction with the care of the relative(Between the initial visit, the 3-month visit, and the 6-months visit)
- The feasibility of home teleconsultation for ALS patients(Between the initial visit, the 3-month visit, and the 6-months visit)
- Evolution of the patient's physical functions(Between the initial visit, the 3-month visit, and the 6-months visit)
- Retention of follow-up modality(At 6 months)
- 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(Between the 3-month visit, and the 6-months visit)
- Physician satisfaction with teleconsultation(After each teleconsultation (3-month visit and 6-month visit))
- Non-inferiority of ventilatory efficiency compared to conventional management(Between the initial visit, the 3-month visit, and the 6-months visit)
- 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(Between the initial visit, the 3-month visit, and the 6-months visit)