Satisfaction of Patients With Amyotrophic Lateral Sclerosis Regarding Home Assisted Teleconsultation

ALS Clinical Trial

— VNI_SLA  

Official title:

Satisfaction of Patients With Amyotrophic Lateral Sclerosis Under Non-invasive Ventilation Regarding Home Assisted Teleconsultation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05621213
• Other study ID #: 2022-A01667-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2022
• Source: AGIR à Dom
• Contact: Céline Barra
• Phone: 0750543238
• Email: c.barra[@]agiradom.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Satisfaction of patients with amyotrophic lateral sclerosis under non-invasive ventilation regarding home assisted teleconsultation

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with a diagnosis of ALS coming for a follow-up consultation with their pneumologist
• Daily NIV compliance of more than 4 hours in the month prior to inclusion
• Living at home
• Patient with a natural caregiver
• Patient equipped with computer equipment adapted for teleconsultation (tablet, computer, telephone... with an internet connection)
• Patient able to read and understand the procedure, and able to express consent for the study protocol
• Patient, or his or her caregiver, able to sign the consent to participate by himself or herself

Exclusion Criteria:

• Patient not available or wishing to change region within 3 months of inclusion
• Patient currently participating or having participated in the month prior to inclusion in another clinical interventional research study that may have an impact on the study, this impact is left to the discretion of the investigator
• Persons referred to in articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons)
• Pregnant women (for women of childbearing age and in the absence of reliable contraception, the ß-HCG (human chorionic gonadotropin) assay will be performed), parturient women, breastfeeding women,
• persons deprived of their liberty by judicial or administrative decision,
• persons under legal protection

Related Conditions & MeSH terms

• ALS
• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

Other:
• Teleconsultation assisted by a physiotherapist or nurse
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.

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	Grenoble
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
AGIR à Dom

Country where clinical trial is conducted

France, 

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