Clinical trial NCT05837507: Amyotrophic Lateral Sclerosis Non-invasive Ventilation Exchange
Official title: Contribution of a Multimodal Digital Platform in the Management and Follow-up of Patients With Amyotrophic Lateral Sclerosis Treated With Non-invasive Ventilation: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis (ALS)
Non invasive ventilation
Telemonitoring
Telemedicine
Multidisciplinary approach
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Université Montpellier
First posted: 2023-05-01
Enrollment: 58
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, two-armed, interventional controlled study versus multicenter, open-label study.
Primary purpose: TREATMENT

Brief summary: The median survival of patients with amyotrophic lateral sclerosis (ALS) is 3 to 5 years and mortality is mainly related to respiratory failure. Non-invasive ventilation (NIV) and multidisciplinary management improve the quality of life and survival of patients. However, patients have mobility difficulties related to the progressive worsening of functional disabilities. The research team hypothesize that the use of a multimodal digital platform, including in particular telemonitoring of NIV and teleconsultation, will slow down the evolution of the disabilities of patients with ALS and improve their quality of life.

Detailed description: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with a median life expectancy of 3 to 5 years. Respiratory failure due to alveolar hypoventilation is the main cause of mortality and respiratory impairment leads to a significant deterioration in quality of life.

Non-invasive ventilation (NIV) improves patient quality of life, improves gas exchange and improves patient survival. NIV should be initiated early, based on symptomatology and lung function, and monitored closely to adjust device parameters. NIV is a complex intervention that must be individualized for each patient.

In addition, multidisciplinary management involving different healthcare professionals, keeping the patient and caregivers at the center of the network, also allows for an improvement in the quality of life and survival of these patients.

However, patients with ALS have difficulty moving around and access to care becomes more complicated as the disease progresses. This phenomenon was increased during the COVID- 19 pandemic with a more rapid functional decline.

The development of new technologies should make it possible to rethink patient management, in particular through remote monitoring of NIV devices, teleconsultation, administration of questionnaires and better interprofessional organization. Several studies have confirmed the feasibility and acceptance of telemedicine solutions in this population.

In this project, The research team hypothesize that the use of a multimodal digital platform will slow the progression of disability in ALS patients and improve their quality of life, in particular by improving the quality of NIV and optimizing the coordination of a multidisciplinary team.

Eligibility criteria: Inclusion Criteria:

* Patients between 30 and 85 years old
* Diagnosis of ALS
* Indication and acceptance of non-invasive ventilation
* Patient equipped with suitable equipment (tablet, computer, telephone, etc.) with an internet connection at home
* Patient able to read and understand the procedure, and able to express consent for the study protocol

Exclusion Criteria:

* Treatment with non-invasive ventilation in the previous three months
* Refusal/inability to use a smart phone or digital device
* Patient currently participating or having participated in the month preceding inclusion in another clinical interventional research that could impact the study, this impact is left to the discretion of the investigator.
* Subject under guardianship or curators
* Subject not affiliated to a social security scheme, or not a beneficiary of such a scheme.
* Subject deprived of liberty by judicial or administrative decision
* Pregnant, parturient, breastfeeding women
* Refusal to give consent

Primary outcomes:
measure: Difference in change in functional abilities between the experimental and control groups over 6 months of follow-up.
timeFrame: Between baseline and 6 months
Secondary outcomes:
measure: Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between 3 months and 6 months).
timeFrame: Between 3 months and 6 months
measure: Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between Baseline and 3 months).
timeFrame: Between Baseline and 3 months
measure: Evolution of dyspnea between the 2 groups between baseline and 3 months
timeFrame: Between Baseline and 3 months
measure: Evolution of dyspnea between the 2 groups between baseline and 6 months
timeFrame: Between Baseline and 6 months
measure: Evolution of Quality of life between the 2 groups between baseline and 3 months
timeFrame: Between Baseline and 3 months
measure: Evolution of Quality of life between the 2 groups between baseline and 6 months
timeFrame: Between Baseline and 6 months
measure: Evolution of evaluation of Anxiety and depression between the 2 groups between baseline and 3 months
timeFrame: Between Baseline and 3 months
measure: Evolution of evaluation of Anxiety and depression between the 2 groups between baseline and 6 months
timeFrame: Between Baseline and 6 months
measure: Evolution of Patient satisfaction between the 2 groups between baseline and 3 months
timeFrame: Between Baseline and 3 months
measure: Evolution of Caregivers satisfaction between the 2 groups between baseline and 3 months
timeFrame: Between Baseline and 3 months
measure: Evolution of Patient satisfaction between the 2 groups between baseline and 6 months
timeFrame: Between Baseline and 6 months
measure: Evolution of Caregivers satisfaction between the 2 groups between baseline and 6 months
timeFrame: Between Baseline and 6 months
measure: Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (Weight measurements)
timeFrame: Between Baseline and 3 months
measure: Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (BMI)
timeFrame: Between Baseline and 3 months
measure: Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (weight measurements)
timeFrame: Between Baseline and 6 months
measure: Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (BMI)
timeFrame: Between Baseline and 6 months
measure: Evaluation of the quality and tolerance of NIV between the 2 groups at 3 months
timeFrame: At 3 months
measure: Evaluation of the quality and tolerance of NIV between the 2 groups at 6 months
timeFrame: At 6 months
measure: Evaluation of the effectiveness of NIV between the 2 groups at 3 months assessed by nocturnal oximetry
timeFrame: At 3 months
measure: Evaluation of the effectiveness of NIV between the 2 groups at 6 months assessed by nocturnal oximetry
timeFrame: At 6 months
measure: Evaluation of the effectiveness of NIV between the 2 groups at 3 months assessed by nocturnal capnography
timeFrame: At 3 months
measure: Evaluation of the effectiveness of NIV between the 2 groups at 6 months assessed by nocturnal capnography
timeFrame: At 6 months
measure: Evaluation of the NIV parameters between the 2 groups at 3 months
timeFrame: At 3 months
measure: Evaluation of the NIV parameters between the 2 groups at 6 months
timeFrame: At 6 months
measure: Evaluation of survival between the 2 groups at 3 months
timeFrame: At 3 months
measure: Evaluation of survival between the 2 groups at 6 months
timeFrame: At 6 months
measure: Evaluation of time to first hospitalization between the 2 groups at 3 months
timeFrame: At 3 months
measure: Evaluation of time to first hospitalization between the 2 groups at 6 months
timeFrame: At 6 months
measure: Evaluation at 3 months in the experimental group of the Satisfaction of professionals with the digital solution
timeFrame: At 3 months
measure: Evaluation at 6 months in the experimental group of the Satisfaction of professionals with the digital solution
timeFrame: At 6 months
measure: Medico-economic evaluation: incremental cost-utility ratio
timeFrame: 6 months
measure: Evaluation at 3 months in the experimental group of the Patient satisfaction with the digital solution
timeFrame: At 3 months
measure: Evaluation at 6 months in the experimental group of the Patient satisfaction with the digital solution
timeFrame: At 6 months
measure: Evaluation at 3 months in the experimental group of the caregiver satisfaction with the digital solution
timeFrame: At 3 months
measure: Evaluation at 6 months in the experimental group of the caregiver satisfaction with the digital solution
timeFrame: At 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
city: Montpellier
country: France
facility: Clinique du Millénaire
Study officials:
affiliation: University Hospital, Montpellier
name: Francois BUGHIN, MD
role: STUDY_DIRECTOR
References: