Amyotrophic Lateral Sclerosis Non-invasive Ventilation Exchange

NCT ID: NCT05837507

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-05
• Study Completion Date: 2025-05-31

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

A group of 29 patients with ALS will be formed to the multimodal digital platform associated with Non Invasive Ventilation (NIV) and usual management

Patients will be treated with NIV equipment from the manufacturer LOWENSTEIN and will benefit from the usual follow-up carried out at the reference center of Montpellier University Hospital.

Group Type: EXPERIMENTAL

Telerehabilitation solution (m-Rehab)

Intervention Type: OTHER

Patients in the experimental group will have access to a multimodal digital platform (m-Rehab®). The solution includes a website and an application available on smart phones for the patient and caregivers. Patients and caregivers will have access to educational content about the condition and its treatments, NIV compliance data, digital group educational workshops, secure messaging and video conferencing.

All the professionals forming the patient's circle of care will be able to have access to the solution, after the patient's authorization. The circle of care, in a non-exhaustive way, includes specialist doctors, the general practitioner, the staff of the reference center of the Montpellier University Hospital, the physiotherapist, the speech therapist, the dietician and the psychologist.

Usual management including NIV.

Intervention Type: OTHER

Usual management including NIV.

Control Comparator

A group of 29 patients with ALS will be formed : control group following usual management including NIV.

Patients will be treated with NIV equipment from the manufacturer LOWENSTEIN and will benefit from the usual follow-up carried out at the reference center of Montpellier University Hospital.

Group Type: ACTIVE_COMPARATOR

Usual management including NIV.

Intervention Type: OTHER

Usual management including NIV.

Interventions

Telerehabilitation solution (m-Rehab)

Patients in the experimental group will have access to a multimodal digital platform (m-Rehab®). The solution includes a website and an application available on smart phones for the patient and caregivers. Patients and caregivers will have access to educational content about the condition and its treatments, NIV compliance data, digital group educational workshops, secure messaging and video conferencing.

All the professionals forming the patient's circle of care will be able to have access to the solution, after the patient's authorization. The circle of care, in a non-exhaustive way, includes specialist doctors, the general practitioner, the staff of the reference center of the Montpellier University Hospital, the physiotherapist, the speech therapist, the dietician and the psychologist.

Intervention Type: OTHER

Usual management including NIV.

Usual management including NIV.

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Université Montpellier

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francois BUGHIN, MD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Uh Montpellier

Montpellier, , France

Site Status: RECRUITING

Clinique du Millénaire

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Francois BUGHIN, MD

Role: CONTACT

f-bughin@chu-montpellier.fr

04.67.33.82.84 ext. 33

Facility Contacts

FRANCOIS BUGHIN, MD

Role: primary

f-bughin@chu-montpellier.fr

04.67.33.82.84 ext. 33

Francois BUGHIN, MD

Role: primary

f.bughin@millenaire.fr

Other Identifiers

RECHMPL23_0054

Identifier Type: -

Identifier Source: org_study_id