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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

NCT04615078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-06-26

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Air Liquide Santé International

    lead INDUSTRY

Principal Investigators

  • Arnaud PRIGENT, MD · Groupe Médical de Pneumologie, Polyclinique Saint Laurent - 35706 - Rennes - France

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2022-07-25
Completion
2022-07-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04615078 on ClinicalTrials.gov