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 | Completed

• 2 other identifiers: ALMED-20-0012020-A02150-39
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 11

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.

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

Outcome Measures

Primary Outcomes (1)

• Nocturnal alveolar hypoventilation data

  Average PtCO2, measured by transcutaneous capnography

  6th month

Secondary Outcomes (6)

• Number of medical events (consultations, hospitalizations and COPD exacerbations) related to Chronic Respiratory Failure

  6th month; 12th month

• Measurement of diurnal PaO2 and PaCO2

  6th month

• S3-NIV questionnaire

  Through study completion, an average estimated at around 7 months

• DIRECT questionnaire

  1st month; 6th month

• Quality of NIV treatment

  Through study completion, an average estimated at around 7 months

Study Arms (2)

"Telemonitoring" group

EXPERIMENTAL

Medical Telemonitoring in Non-Invasive Ventilation

Device: ETAPES Program

"Standard of Care" group

NO INTERVENTION

Standard medical follow-up: standard home Non-Invasive Ventilation service, with transmission of their ventilator data without analysis leading to alerts

Interventions

ETAPES Program DEVICE

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.

Also known as: Chronic Care Connect Pneumology Solution

"Telemonitoring" group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Liquide Santé International: lead

Study Sites (11)

Centre Hospitalier de Boulogne sur Mer

Boulogne-sur-Mer, 62321, France

Location

Centre Hospitalier de Bligny

Briis-sous-Forges, 91640, France

Location

Claude SCHMITZ, MD

Colmar, 68000, France

Location

Hôpital Forcilles - Fondation Cognacq-Jay

Férolles-Attilly, 77150, France

Location

François BUGHIN, MD - Clinique du Millénaire

Montpellier, 34000, France

Location

Clinique FSEF Paris 16ème

Paris, 75016, France

Location

Groupe Hospitalier Pitié Salpêtrière-Charles Foix

Paris, 75651 cedex 13, France

Location

Groupe Médical de Pneumologie, Polyclinique Saint Laurent

Rennes, 35706, France

Location

Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey

Toulouse, 31059, France

Location

Centre Hospitalier Universitaire de Tours - Hôpital Bretonneau

Tours, 37044, France

Location

Pierre-Henri GUILLAUD, MD

Vienne, 38200, France

Location

Related Publications (1)

• Prigent A, Texereau JB, Schmitz C, Ropars C, Degreef JM, Teulier M, Darne C, Lavergne F, Pasche H, Morelot-Panzini C. Real-world telemonitoring and remote support for home non-invasive ventilation to improve therapy effectiveness: the exploratory, multicentre randomised eVENT study. Thorax. 2025 Sep 15;80(10):720-729. doi: 10.1136/thorax-2024-222033.

  PMID: 40169180 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Arnaud PRIGENT, MD

  Groupe Médical de Pneumologie, Polyclinique Saint Laurent - 35706 - Rennes - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: November 4, 2020
• Study Start: January 18, 2021
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

FR (11)