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)

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Obesity Hypoventilation Syndrome (OHS); Chronic Respiratory Failure With Hypercapnia
• Intervention / Treatment: Device: ETAPES Program

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Boulogne-sur-Mer, France, 62321
    • Centre Hospitalier de Boulogne Sur Mer
  • Briis-sous-Forges, France, 91640
    • Centre Hospitalier de Bligny
  • Colmar, France, 68000
    • Claude SCHMITZ, MD
  • Férolles-Attilly, France, 77150
    • Hôpital Forcilles - Fondation Cognacq-Jay
  • Montpellier, France, 34000
    • François BUGHIN, MD - Clinique du Millénaire
  • Paris, France, 75016
    • Clinique FSEF Paris 16ème
  • Paris, France, 75651 cedex 13
    • Groupe Hospitalier Pitié Salpêtrière-Charles Foix
  • Rennes, France, 35706
    • Groupe Médical de Pneumologie, Polyclinique Saint Laurent
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
  • Tours, France, 37044
    • Centre Hospitalier Universitaire de Tours - Hôpital Bretonneau
  • Vienne, France, 38200
    • Pierre-Henri GUILLAUD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with chronic respiratory failure for whom treatment with home NIV was prescribed at inclusion or two months earlier, and whose service provider is ADEP Assistance, ADAIR Assistance, ARAIR Assistance or VitalAire,

• Patient who meets all eligibility criteria to participate in the ETAPES program, namely:

  • Patient aged 18 and over;
  • Patient receiving NIV as part of an indication recognized by the Société de Pneumologie de Langue Française and the Haute Autorité de Santé;
• Patient never before included in the ETAPES program for the remote medical monitoring of their chronic respiratory failure;
• Patient having agreed to participate in the ETAPES program with the Chronic Care Connect Pneumology solution operated by the service providers ADEP Assistance, ADAIR Assistance, ARAIR Assistance or VitalAire, in the event that they are randomized to the Remote Medical Monitoring group;
• Patient agreeing to the collection of data from their ventilator via remote transmission;
• Patient fitted with a ventilator compatible with the Chronic Care Connect Pneumology solution;
• Patient with health insurance cover;
• Patient who has signed the consent form for the study.

Exclusion Criteria:

• Patient who has any of the non-eligibility criteria for the ETAPES program:

  • Physical or mental inability to use all components of the remote medical monitoring project, as determined by the doctor wishing to include the patient in the remote medical monitoring project;
  • Patient with cancer with a life expectancy of less than 12 months estimated by the pulmonologist;
  • Patient with more than three COPD respiratory decompensations resulting in hospitalization within the previous 12 months;
  • Patient with diagnosed neuromuscular disease;
  • Estimated poor compliance or standard adherence to treatment according to the physician including the patient;
  • Patient's refusal of treatment support;
  • No permanent place of residence;
• Patient participating in another intervention research program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Telemonitoring" group; Medical Telemonitoring in Non-Invasive Ventilation	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.; Other Names: Chronic Care Connect Pneumology Solution
No Intervention: "Standard of Care" group; Standard medical follow-up: standard home Non-Invasive Ventilation service, with transmission of their ventilator data without analysis leading to alerts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal alveolar hypoventilation data	Average PtCO2, measured by transcutaneous capnography	6th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of medical events (consultations, hospitalizations and COPD exacerbations) related to Chronic Respiratory Failure	Average number of medical events (consultations, hospitalizations and COPD exacerbations) related to Chronic Respiratory Failure per patient	6th month; 12th month
Measurement of diurnal PaO2 and PaCO2	Measurement of diurnal PaO2 and PaCO2 (mmHg) without NIV, in stable state at rest	6th month
S3-NIV questionnaire	Questionnaire evaluating sleep, side effects and symptoms in patients on home NIV, each time the service provider visits the patient at home	Through study completion, an average estimated at around 7 months
DIRECT questionnaire	Total health-related quality-of-life score from the DIRECT questionnaire as recommended in the ETAPES program, submitted to the patients in the month following their inclusion and in the 6th month	1st month; 6th month
Quality of NIV treatment	Daily data teletransmitted by ventilators throughout the follow-up period	Through study completion, an average estimated at around 7 months
Patient satisfaction questionnaire about Telemonitoring services	Questionnaire developed for the study to collect patient satisfaction about the educational component of the telemonitoring service at the end of their participation to the study	6th month

Collaborators and Investigators

• Sponsor: Air Liquide Santé International
• Investigators: Principal Investigator: Arnaud PRIGENT, MD, Groupe Médical de Pneumologie, Polyclinique Saint Laurent - 35706 - Rennes - France

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Telemonitoring; Non-invasive ventilation; Remote Patient Management; ETAPES; Home healthcare provider; Chronic Care Connect Pneumology
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Disease Attributes; Overnutrition; Nutrition Disorders; Overweight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Obesity; Sleep Apnea, Obstructive; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome; Hypercapnia
• Other Study ID Numbers: ALMED-20-001; 2020-A02150-39 (Other Identifier: French National Agency for Medicines and Health Products Safety - ANSM (ID-RCB))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No