Clinical trial 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Respiratory Failure With Hypercapnia
Chronic Obstructive Pulmonary Disease (COPD)
Obesity Hypoventilation Syndrome (OHS)
Keywords: Non-invasive ventilation
Telemonitoring
Remote Patient Management
ETAPES
Home healthcare provider
Chronic Care Connect Pneumology
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nocturnal alveolar hypoventilation data
timeFrame: 6th month
Secondary outcomes:
measure: Number of medical events (consultations, hospitalizations and COPD exacerbations) related to Chronic Respiratory Failure
timeFrame: 6th month; 12th month
measure: Measurement of diurnal PaO2 and PaCO2
timeFrame: 6th month
measure: S3-NIV questionnaire
timeFrame: Through study completion, an average estimated at around 7 months
measure: DIRECT questionnaire
timeFrame: 1st month; 6th month
measure: Quality of NIV treatment
timeFrame: Through study completion, an average estimated at around 7 months
measure: Patient satisfaction questionnaire about Telemonitoring services
timeFrame: 6th month
Other outcomes:
Locations:
city: Boulogne-sur-Mer
country: France
facility: Centre Hospitalier de Boulogne sur Mer
city: Briis-sous-Forges
country: France
facility: Centre Hospitalier de Bligny
city: Colmar
country: France
facility: Claude SCHMITZ, MD
city: Férolles-Attilly
country: France
facility: Hôpital Forcilles - Fondation Cognacq-Jay
city: Montpellier
country: France
facility: François BUGHIN, MD - Clinique du Millénaire
city: Paris
country: France
facility: Clinique FSEF Paris 16ème
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière-Charles Foix
city: Rennes
country: France
facility: Groupe Médical de Pneumologie, Polyclinique Saint Laurent
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey
city: Tours
country: France
facility: Centre Hospitalier Universitaire de Tours - Hôpital Bretonneau
city: Vienne
country: France
facility: Pierre-Henri GUILLAUD, MD
Study officials:
affiliation: Groupe Médical de Pneumologie, Polyclinique Saint Laurent - 35706 - Rennes - France
name: Arnaud PRIGENT, MD
role: PRINCIPAL_INVESTIGATOR
References: