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The study was terminated early due to insufficient recruitment despite mitigation measures, as enrolment rates could not meet protocol objectives. Academic thesis scheduling constraints also contributed. No safety concerns were identified.
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Satisfaction of patients with amyotrophic lateral sclerosis under non-invasive ventilation regarding home assisted teleconsultation
Amyotrophic Lateral Sclerosis (ALS) is a progressive and rapidly progressing neurodegenerative disease. Depending on the degree of muscle damage, patients may suffer from reduced mobility, difficulty swallowing, speech difficulties and finally respiratory weakness. Death occurs within an average of 2-3 years and is usually due to respiratory failure. Currently there is no cure for ALS, so palliative care and symptomatic treatments are essential for the management of these patients.
The gold standard treatment for respiratory impairment is non-invasive ventilation (NIV). The aim of this mask ventilation is to improve gas exchange by compensating for the weakness of the respiratory muscles.
The progressive nature of ALS requires regular assessment of the patient's clinical condition and evaluation of NIV parameters. Regular medical appointments are therefore essential to ensure optimal ventilation and close surveillance of the patient. A day hospitalization or a consultation is organized every 3 or 4 months. These visits can cause significant fatigue, not only because of the difficulty patients have to move around but also because of the time spent waiting in hospital.
ALS is characterised by its severity and it requires our society to think about and implement new ways of managing the disease. Thus, e-health innovations could be an interesting potential in the remote follow-up of these patients, to reduce the burden of hospital consultations.
The hypothesis is that the patient will be more satisfied with a home assisted teleconsultation follow-up, while keeping the same quality of non-invasive nocturnal ventilatory assistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients who will be followed up by teleconsultation assisted by a physiotherapist or a nurse at home. |
|
| Control group | No Intervention | Patients not wishing to be followed up by teleconsultation but agreeing to participate in the study and the collection of questionnaires. They will follow up as usual in person (no teleconsultation). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teleconsultation assisted by a physiotherapist or nurse | Other | A home health care provider (with expertise in NIV) will be asked to attend the 2 home teleconsultation sessions. This assistance will make it possible to help, if necessary, the patient to settle in and connect, collect the elements necessary for the doctor's consultation and adjust, if necessary, the NIV settings. He will also be responsible for administering the questionnaires to the patient as well as to his family caregiver. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Non-inferiority of ventilatory efficiency compared to conventional management |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christel Saint-Raymond, PhD | CHU Grenoble Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble Alpes | Grenoble | France | 38043 | France | ||
| CHU Montpellier |
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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 |
|---|---|
| D009726 | Nurses |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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Patient assigned to the interventional group or to the control group if they do not wish to be followed up by teleconsultation
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| Montpellier |
| France |
| 34295 |
| France |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |