NCT04615078

Study Evaluating Telemonitoring and Experimentation in Telemedicine for the Improvement of Healthcare Pathways (ETAPES Program) Compared to Standard of Care in Patients With Chronic Respiratory Failure Receiving Non-invasive Home Ventilation

Multi-center, National, Randomized, Exploratory Study Evaluating Telemonitoring and Experimentation in Telemedicine for the Improvement of Healthcare Pathways (ETAPES Program) Compared to Standard of Care in Patients With Chronic Respiratory Failure Receiving Non-invasive Home Ventilation (e-VENT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Air Liquide Santé International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ETAPES Program, a French national Experimentation in Telemedicine for the Improvement of Healthcare Pathways, was launched in 2018 for 4 years. Its objectives were to provide a temporary public reimbursement for medical telemonitoring in order to determine the benefits for the patient and the impact on medical organization and healthcare costs. In particular, this program applies to patients suffering from hypercapnic chronic respiratory failure and requiring home non invasive ventilation (NIV). For these patients, the ETAPES program combines NIV telemonitoring and therapeutic education. e-VENT study aims at evaluating the ETAPES program, implemented using the Chronic Care Connect™ telemonitoring solution, versus Standard of Care, on the effectiveness of home NIV, measured by average PtCO2, reflecting the level of nocturnal alveolar hypoventilation.

Detailed description

A prospective randomized study with two arms. The primary endpoint is the level of nocturnal alveolar hypoventilation, defined as the average PtCO2 in nocturnal capnography performed at 6th month. Patients with hypercapnic chronic respiratory failure requiring home NIV (n=100). Multi-center study conducted in France involving approximately 20 sites Product under study: Chronic Care Connect Pneumology telemonitoring solution, combining: * a technical solution for the transmission and analysis of ventilator data, with the generation of alerts by a CE-marked algorithm; * an organizational solution relying on a nurse call center. Study design: * First visit: eligibility criteria confirmation; randomization to 2 groups: * the "Telemonitoring" group will participate in the ETAPES experimentation, with remote monitoring of their ventilator data with generation of alerts to the nurse call center, medical action if requested, and therapeutic education. * the "Standard of Care" group will receive standard medical follow-up, with transmission of their ventilator data without generation of alerts. * Second visit (6th month): arterial blood gases, nocturnal capnography. Collection of medical events having occurred in the past 6 months. * Third visit (12th month): for COPD patients only - Collection of medical events having occurred in the past 6 months. * At the end of the study, the investigators will complete a qualitative questionnaire on their telemonitoring practice.

Conditions

• Chronic Respiratory Failure With Hypercapnia
• Chronic Obstructive Pulmonary Disease (COPD)
• Obesity Hypoventilation Syndrome (OHS)

Interventions

Type	Name	Description
DEVICE	ETAPES Program	The Chronic Care Connect Pneumology is a remote medical monitoring solution, combining: * A technical solution for the transmission and analysis of ventilator data, leading to alerts generated by an algorithm ; * An organizational solution relying on a nurse call center.

Timeline

• Start date: 2021-01-18
• Primary completion: 2022-07-25
• Completion: 2022-07-25
• First posted: 2020-11-04
• Last updated: 2023-06-26

Locations

11 sites across 1 country: France