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Amyotrophic Lateral Sclerosis Non-invasive Ventilation Exchange

NCT05837507 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-07-11

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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.

OTHER

Usual management including NIV.

Usual management including NIV.

Sponsors & Collaborators

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

    collaborator OTHER_GOV

  • Université Montpellier

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Francois BUGHIN, MD · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-05
Primary Completion
2024-11-30
Completion
2025-05-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05837507 on ClinicalTrials.gov