Satisfaction of Patients With Amyotrophic Lateral Sclerosis Regarding Home Assisted Teleconsultation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-13

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nocturnal PtcCO2 Monitoring in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT00879593

Amyotrophic Lateral Sclerosis

COMPLETED NA

Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)

NCT00613899

Amyotrophic Lateral Sclerosis

COMPLETED PHASE4

Effects of Gastrostomy on Amyotrophic Lateral Sclerosis

NCT00337402

Amyotrophic Lateral Sclerosis

COMPLETED

Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality

NCT06021938

Amyotrophic Lateral Sclerosis

RECRUITING NA

Modeling Amyotrophic Lateral Sclerosis With Fibroblasts

NCT06450691

Amyotrophic Lateral Sclerosis

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ALS Charcot Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patient assigned to the interventional group or to the control group if they do not wish to be followed up by teleconsultation

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Patients who will be followed up by teleconsultation assisted by a physiotherapist or a nurse at home.

Group Type EXPERIMENTAL

Teleconsultation assisted by a physiotherapist or nurse

Intervention Type OTHER

A home health care provider (with expertise in NIV) will be asked to attend the 2 home teleconsultation sessions.

This assistance will make it possible to help, if necessary, the patient to settle in and connect, collect the elements necessary for the doctor's consultation and adjust, if necessary, the NIV settings. He will also be responsible for administering the questionnaires to the patient as well as to his family caregiver.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Teleconsultation assisted by a physiotherapist or nurse

A home health care provider (with expertise in NIV) will be asked to attend the 2 home teleconsultation sessions.

This assistance will make it possible to help, if necessary, the patient to settle in and connect, collect the elements necessary for the doctor's consultation and adjust, if necessary, the NIV settings. He will also be responsible for administering the questionnaires to the patient as well as to his family caregiver.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No