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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— e-VENT  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04615078
• Other study ID #: ALMED-20-001
• Secondary ID: 2020-A02150-39
• Status: Completed
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: July 25, 2022

Study information

• Verified date: June 2023
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 25, 2022
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier de Boulogne sur Mer	Boulogne-sur-Mer
France	Centre Hospitalier de Bligny	Briis-sous-Forges
France	Claude SCHMITZ, MD	Colmar
France	Hôpital Forcilles - Fondation Cognacq-Jay	Férolles-Attilly
France	François BUGHIN, MD - Clinique du Millénaire	Montpellier
France	Clinique FSEF Paris 16ème	Paris
France	Groupe Hospitalier Pitié Salpêtrière-Charles Foix	Paris
France	Groupe Médical de Pneumologie, Polyclinique Saint Laurent	Rennes
France	Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey	Toulouse
France	Centre Hospitalier Universitaire de Tours - Hôpital Bretonneau	Tours
France	Pierre-Henri GUILLAUD, MD	Vienne

Sponsors (1)

Lead Sponsor	Collaborator
Air Liquide Santé International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nocturnal alveolar hypoventilation data	Average PtCO2, measured by transcutaneous capnography	6th month
Secondary	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
Secondary	Measurement of diurnal PaO2 and PaCO2	Measurement of diurnal PaO2 and PaCO2 (mmHg) without NIV, in stable state at rest	6th month
Secondary	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
Secondary	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
Secondary	Quality of NIV treatment	Daily data teletransmitted by ventilators throughout the follow-up period	Through study completion, an average estimated at around 7 months
Secondary	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