Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home.

Study Overview
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Brief Summary
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Single-center, prospective pilot study on patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. The objective is to assess the satisfaction of remote monitoring of patients on non-invasive ventilation after 12 months.

Detailed Description
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The non invasive ventilation is one of treatments used during the amyotrophic lateral sclerosis when patients have a chronic respiratory failure with alveolar hypoventilation signs. It is demonstrated to improve quality of life and prognosis of the disease. These patients, often severely disabled, generally have a negative experience of repeated hospitalizations. Despite everything, medical and paramedical monitoring is necessary, especially when they are fitted with non invasive ventilation (NIV). A quarterly reassessment is recommended . The possibilities of telemonitoring at home have grown considerably in recent years. In addition, the fans are currently able to remotely transfer a certain amount of data to the service provider, making remote monitoring feasible.Our project therefore aims to assess the feasibility of remote monitoring of patients with Amyotrophic Lateral Sclerosis (ALS) fitted with non invasive ventilation (NIV) through the assessment of their satisfaction, using both medical data and data provided by the ventilator. It is a single-center, prospective pilot study on 30 patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. Patients will benefit from a quarterly teleconsultation to assess the study criteria through questionnaires during 12 months. Ventilation machines make it possible to carry out remote monitoring, with the help of healthcare providers.

Official Title
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Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home. Tele Monitoring Ventilation At Home (TM-VAH)

Conditions
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Amyotrophic Lateral Sclerosis, Noninvasive Ventilation

Intervention / Treatment
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* Other: teleconsultation


Participation Criteria
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Eligibility Criteria
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o inclusion criteria: Patient over 18 years, Patient with Amyotrophic Lateral Sclerosis (ALS), Already fitted by Non Invasive Ventilation (NIV), Patient having signed the informed consent Patient affiliated to a social security scheme, Patient with a correct understanding of the French language, Patient with access to an internet connection at home. For the caregiver: Adult person Be the patient's primary caregiver Have signed the informed consent intended for the caregiver o exclusion criteria: Patient with another cause of chronic respiratory failure: other neuromuscular diseases, Chronic obstructive pulmonary disease (COPD), diffuse interstitial lung disease, Patient under guardianship or under judicial protection, Patient dependent at least 20 hours out of 24 of the non invasive Ventilation (NIV).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telemonitoring of non invasive ventilation at home<br>Patients will benefit from a quarterly teleconsultation to assess the study criteria through different questionnaires during 12 months. Ventilation machines make it possible to carry out remote monitoring, with the help of healthcare providers. | Other: teleconsultation<br>* Patients will benefit from a quarterly teleconsultation to assess the study criteria through different questionnaires during 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction of the telemonitoring of non invasive ventilation at home assessed by CSQ-8 at the end of the study | Consumer satisfaction questionnaire (CSQ-8), minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of remote monitoring | evaluated by teleconsultation | every 3 months during 1 year | 
| Patient satisfaction during the study | assessed by Consumer satisfaction questionnaire (CSQ-8), minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied. | every 3 months during 1 year | 
| Feasibility for caregivers assessed by Zarit questionnaire | Painfulness or burden assessment scale. Minimal score is 0 and maximal score is 76. the higher the score, the greater the difficulty. | every 3 months during 1 year | 
| Feasibility for caregivers assessed by Depression Anxiety Stress Scales (DASS-21) questionnaire | Painfulness or burden assessment scale. Minimal score is 0 and maximal score is 63. the higher the score, the greater the depression. | every 3 months during 1 year | 
| Feasibility for nursing staff | data collected through remote monitoring | every 3 months during 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemonitoring, amyotrophic lateral sclerosis, noninvasive ventilation, feasibility