Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between 3 months and 6 months).
Difference in variation of the functional capabilities assessed by the Amyotrophic lateral sclerosis functional rating scale (ALSFRS) score at 3 month and 6 month between the experimental group and the control group.
A scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality
Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between Baseline and 3 months).
Difference in variation of the functional capabilities assessed by the ALSFRS score at Baseline (D0) and 3 month between the experimental group and the control group.
A scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality
Evolution of dyspnea between the 2 groups between baseline and 3 months
Dyspnea assessed by modified Borg scale. Minimum is 0 (best). Maximum is 10 (worse).
Evolution of dyspnea between the 2 groups between baseline and 6 months
Dyspnea assessed by modified Borg scale. Minimum is 0 (best). Maximum is 10 (worse).
Evolution of Quality of life between the 2 groups between baseline and 3 months
Quality of life assessed by the EuroQol-5 Dimensions (EQ5D) scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Evolution of Quality of life between the 2 groups between baseline and 6 months
Quality of life assessed by the EQ5D scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Evolution of evaluation of Anxiety and depression between the 2 groups between baseline and 3 months
Anxiety and depression assessed by the Hospital Anxiety and Depression (HAD) scale.
The HAD results in a score ranging from 0 (low anxiety or depression) to 21 (strong anxiety or depression).
Evolution of evaluation of Anxiety and depression between the 2 groups between baseline and 6 months
Anxiety and depression assessed by the HAD scale. The HAD results in a score ranging from 0 (low anxiety or depression) to 21 (strong anxiety or depression).
Evolution of Patient satisfaction between the 2 groups between baseline and 3 months
Patient satisfaction assessed by the CSQ-8 (Consumer satisfaction questionnaire) Minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.
Evolution of Caregivers satisfaction between the 2 groups between baseline and 3 months
Caregivers satisfaction assessed by the CSQ-8. Minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.
Evolution of Patient satisfaction between the 2 groups between baseline and 6 months
Patient satisfaction assessed by the CSQ-8. Minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.
Evolution of Caregivers satisfaction between the 2 groups between baseline and 6 months
Caregivers satisfaction assessed by the CSQ-8. Minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.
Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (Weight measurements)
Weight measurements
Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (BMI)
BMI
Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (weight measurements)
weight measurements
Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (BMI)
BMI
Evaluation of the quality and tolerance of NIV between the 2 groups at 3 months
The quality and tolerance of NIV assessed by the S3-NIV score. Score 0 to 10, lower units represent worse outcome.
Evaluation of the quality and tolerance of NIV between the 2 groups at 6 months
The quality and tolerance of NIV assessed by the S3-NIV score. Score 0 to 10, lower units represent worse outcome.
Evaluation of the effectiveness of NIV between the 2 groups at 3 months assessed by nocturnal oximetry
The effectiveness of NIV assessed by nocturnal oximetry
Evaluation of the effectiveness of NIV between the 2 groups at 6 months assessed by nocturnal oximetry
The effectiveness of NIV assessed by nocturnal oximetry
Evaluation of the effectiveness of NIV between the 2 groups at 3 months assessed by nocturnal capnography
The effectiveness of NIV assessed by nocturnal capnography
Evaluation of the effectiveness of NIV between the 2 groups at 6 months assessed by nocturnal capnography
The effectiveness of NIV assessed by nocturnal capnography
Evaluation of the NIV parameters between the 2 groups at 3 months
NIV parameters obtained using data from the machine report
Evaluation of the NIV parameters between the 2 groups at 6 months
NIV parameters obtained using data from the machine report
Evaluation of survival between the 2 groups at 3 months
Evaluation of survival between the 2 groups at 3 months
Evaluation of survival between the 2 groups at 6 months
Evaluation of survival between the 2 groups at 6 months
Evaluation of time to first hospitalization between the 2 groups at 3 months
recovery of hospitalization data
Evaluation of time to first hospitalization between the 2 groups at 6 months
recovery of hospitalization data
Evaluation at 3 months in the experimental group of the Satisfaction of professionals with the digital solution
Satisfaction of professionals with the digital solution by a VAS (Visual Analog Scale) of satisfaction
Evaluation at 6 months in the experimental group of the Satisfaction of professionals with the digital solution
Satisfaction of professionals with the digital solution by a VAS (Visual Analog Scale) of satisfaction
Medico-economic evaluation: incremental cost-utility ratio
Utility will be derived from the EQ5D
Evaluation at 3 months in the experimental group of the Patient satisfaction with the digital solution
Patient satisfaction with the digital solution assessed by a VAS (Visual Analog Scale) of satisfaction
Evaluation at 6 months in the experimental group of the Patient satisfaction with the digital solution
Patient satisfaction with the digital solution assessed by a VAS (Visual Analog Scale) of satisfaction
Evaluation at 3 months in the experimental group of the caregiver satisfaction with the digital solution
Caregiver satisfaction with the digital solution assessed by a VAS (Visual Analog Scale) of satisfaction
Evaluation at 6 months in the experimental group of the caregiver satisfaction with the digital solution
Caregiver satisfaction with the digital solution assessed by a VAS (Visual Analog Scale) of satisfaction