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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05621213
Other study ID # 2022-A01667-36
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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