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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| telemonitoring of non invasive ventilation at home | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teleconsultation | Other | Patients will benefit from a quarterly teleconsultation to assess the study criteria through different questionnaires during 12 months. |
|
| 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 |
| 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. |
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o inclusion criteria:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Sandrine Pontier-Marchandise, MD | University Hopsital Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toulouse University Hospital | Toulouse | France |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D019114 | Remote Consultation |
| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| 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 |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |