Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Satisfaction of ALS patients followed by teleconsultation at home |
Evolution of the overall satisfaction score obtained from the Client Satisfaction Questionnaire CSQ-8, with 8 items, score 8-32. The higher the score, the more satisfied the patient is. |
Between the initial visit and the 3-month visit |
|
Secondary |
Evolution of the patient's physical functions |
Change in ALS-FRS-R (Amyotrophic lateral sclerosis functional rating scale revised) questionnaire score, score 0-48. The higher the score, the better the patient's physical function. |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
Non-inferiority of ventilatory efficiency compared to conventional management |
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by S3-NIV (symptoms, sleep quality and side-effects related to the non-invasiv ventilation) questionnaire score 0-10. the higher the score, the fewer ALS-related symptoms the patient has. |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
Non-inferiority of ventilatory efficiency compared to conventional management |
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by mean nocturnal oxygen saturation (SpO2, %) measured by oximetry |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
Non-inferiority of ventilatory efficiency compared to conventional management |
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by time spent (in minutes) below 90% SpO2, measured by oximetry |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
Non-inferiority of ventilatory efficiency compared to conventional management |
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by mean PtCO2 (in mmHg), measured by capnography |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
Non-inferiority of ventilatory efficiency compared to conventional management |
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by time spent (in minutes) above 50 mmHg PtCO2 measured by capnography |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
Non-inferiority of ventilatory efficiency compared to conventional management |
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by the treatment compliance (average daily use) through telemonitoring of the data recorded by the CPAP machine. |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
Non-inferiority of ventilatory efficiency compared to conventional management |
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by the unintentional leakage through telemonitoring of the data recorded by the CPAP machine. |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
Non-inferiority of ventilatory efficiency compared to conventional management |
Non-inferiority of efficiency will be assessed in a blinded manner by two third party experts in ventilation. This ventilatory efficiency will be assessed by the residual Apnea-Hypopnea Index (AHI) through telemonitoring of the data recorded by the CPAP machine. |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit |
Comparison of the evolution of ventilation efficiency assessed from clinical parameters measured by S3-NIV (symptoms, sleep quality and side-effects related to the non-invasiv ventilation) questionnaire, score 0-10. the higher the score, the fewer ALS-related symptoms the patient has. |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit |
Comparison of the evolution of ventilation efficiency assessed from mean PtCO2 (in mmHg), measured by capnography |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit |
Comparison of the evolution of ventilation efficiency assessed from time spent (in minutes) below 90% SpO2, measured by oximetry |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit |
Comparison of the evolution of ventilation efficiency assessed from mean nocturnal oxygen saturation (SpO2,%) measured by oximetry |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit |
Comparison of the evolution of ventilation efficiency assessed from time spent (in minutes) above 50 mmHg PtCO2 measured by capnography |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit |
Comparison of the evolution of ventilation efficiency assessed by the treatment compliance (average daily use) through telemonitoring of the data recorded by the CPAP machine. |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit |
Comparison of the evolution of ventilation efficiency assessed by the unintentional leakage through telemonitoring of the data recorded by the CPAP machine. |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
The evolution of the efficiency of ventilation between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit |
Comparison of the evolution of ventilation efficiency assessed by the residual Apnea-Hypopnea Index (AHI) through telemonitoring of the data recorded by the CPAP machine. |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
Patient satisfaction with teleconsultation itself (use and patient/doctor interaction) |
Evaluation of the score of the Visit Satisfaction Questionnaire (VSQ-VF) score 0-100. The higher the score, the more satisfied the patient is. |
After each teleconsultation (3-month visit and 6-month visit) |
|
Secondary |
The evolution of satisfaction between patients who have completed the teleconsultation follow-up visit and those who have completed the face-to-face follow-up visit |
Comparison of the variation in the score of the visit satisfaction questionnaire, assessed by the VSQ-VF questionnaire, score 0-100. The higher the score, the more satisfied the patient is. |
Between the 3-month visit, and the 6-months visit |
|
Secondary |
Physician satisfaction with teleconsultation |
Evaluation made by Visual Analogue Scale (VAS) from 0 to 10 cm. The higher the score, the more satisfied the physician is. |
After each teleconsultation (3-month visit and 6-month visit) |
|
Secondary |
Caregivers' satisfaction with the care of the relative |
Change in caregiver satisfaction measured with client satisfaction questionnaire score (CSQ-8 modified) with 8 items, score 8-32. The higher the score, the more satisfied the caregivers' is. |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
The feasibility of home teleconsultation for ALS patients |
Number of failed teleconsultations requiring rescheduling |
Between the initial visit, the 3-month visit, and the 6-months visit |
|
Secondary |
Retention of follow-up modality |
Number of patients who changed follow-up modality, assessed by the number of face-to-face follow-up |
At 6 months |
|