Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home.
- Conditions
- Noninvasive VentilationAmyotrophic Lateral Sclerosis
- Interventions
- Other: teleconsultation
- Registration Number
- NCT04797845
- Lead Sponsor
- University Hospital, Toulouse
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description telemonitoring of non invasive ventilation at home teleconsultation 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.
- Primary Outcome Measures
Name Time Method Patient satisfaction of the telemonitoring of non invasive ventilation at home assessed by CSQ-8 at the end of the study 1 year 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.
- Secondary Outcome Measures
Name Time Method Feasibility for caregivers assessed by Zarit questionnaire every 3 months during 1 year Painfulness or burden assessment scale. Minimal score is 0 and maximal score is 76. the higher the score, the greater the difficulty.
Patient satisfaction during the study every 3 months during 1 year 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.
Feasibility for caregivers assessed by Depression Anxiety Stress Scales (DASS-21) questionnaire every 3 months during 1 year Painfulness or burden assessment scale. Minimal score is 0 and maximal score is 63. the higher the score, the greater the depression.
Effect of remote monitoring every 3 months during 1 year evaluated by teleconsultation
Feasibility for nursing staff every 3 months during 1 year data collected through remote monitoring
Trial Locations
- Locations (1)
Toulouse University Hospital
🇫🇷Toulouse, France