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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 (e-VENT)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ETAPES Program
Sponsored by
Air Liquide Santé International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Respiratory Failure With Hypercapnia focused on measuring Non-invasive ventilation, Telemonitoring, Remote Patient Management, ETAPES, Home healthcare provider, Chronic Care Connect Pneumology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier de Boulogne sur Mer
  • Centre Hospitalier de Bligny
  • Claude SCHMITZ, MD
  • Hôpital Forcilles - Fondation Cognacq-Jay
  • François BUGHIN, MD - Clinique du Millénaire
  • Clinique FSEF Paris 16ème
  • Groupe Hospitalier Pitié Salpêtrière-Charles Foix
  • Groupe Médical de Pneumologie, Polyclinique Saint Laurent
  • Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey
  • Centre Hospitalier Universitaire de Tours - Hôpital Bretonneau
  • Pierre-Henri GUILLAUD, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

"Telemonitoring" group

"Standard of Care" group

Arm Description

Medical Telemonitoring in Non-Invasive Ventilation

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

Outcomes

Primary Outcome Measures

Nocturnal alveolar hypoventilation data
Average PtCO2, measured by transcutaneous capnography

Secondary Outcome Measures

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
Measurement of diurnal PaO2 and PaCO2
Measurement of diurnal PaO2 and PaCO2 (mmHg) without NIV, in stable state at rest
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
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
Quality of NIV treatment
Daily data teletransmitted by ventilators throughout the follow-up period
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

Full Information

First Posted
October 20, 2020
Last Updated
June 23, 2023
Sponsor
Air Liquide Santé International
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1. Study Identification

Unique Protocol Identification Number
NCT04615078
Brief Title
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
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
July 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide Santé International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Telemonitoring" group
Arm Type
Experimental
Arm Description
Medical Telemonitoring in Non-Invasive Ventilation
Arm Title
"Standard of Care" group
Arm Type
No Intervention
Arm Description
Standard medical follow-up: standard home Non-Invasive Ventilation service, with transmission of their ventilator data without analysis leading to alerts
Intervention Type
Device
Intervention Name(s)
ETAPES Program
Other Intervention Name(s)
Chronic Care Connect Pneumology Solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nocturnal alveolar hypoventilation data
Description
Average PtCO2, measured by transcutaneous capnography
Time Frame
6th month
Secondary Outcome Measure Information:
Title
Number of medical events (consultations, hospitalizations and COPD exacerbations) related to Chronic Respiratory Failure
Description
Average number of medical events (consultations, hospitalizations and COPD exacerbations) related to Chronic Respiratory Failure per patient
Time Frame
6th month; 12th month
Title
Measurement of diurnal PaO2 and PaCO2
Description
Measurement of diurnal PaO2 and PaCO2 (mmHg) without NIV, in stable state at rest
Time Frame
6th month
Title
S3-NIV questionnaire
Description
Questionnaire evaluating sleep, side effects and symptoms in patients on home NIV, each time the service provider visits the patient at home
Time Frame
Through study completion, an average estimated at around 7 months
Title
DIRECT questionnaire
Description
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
Time Frame
1st month; 6th month
Title
Quality of NIV treatment
Description
Daily data teletransmitted by ventilators throughout the follow-up period
Time Frame
Through study completion, an average estimated at around 7 months
Title
Patient satisfaction questionnaire about Telemonitoring services
Description
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
Time Frame
6th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud PRIGENT, MD
Organizational Affiliation
Groupe Médical de Pneumologie, Polyclinique Saint Laurent - 35706 - Rennes - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Boulogne sur Mer
City
Boulogne-sur-Mer
ZIP/Postal Code
62321
Country
France
Facility Name
Centre Hospitalier de Bligny
City
Briis-sous-Forges
ZIP/Postal Code
91640
Country
France
Facility Name
Claude SCHMITZ, MD
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Name
Hôpital Forcilles - Fondation Cognacq-Jay
City
Férolles-Attilly
ZIP/Postal Code
77150
Country
France
Facility Name
François BUGHIN, MD - Clinique du Millénaire
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Clinique FSEF Paris 16ème
City
Paris
ZIP/Postal Code
75016
Country
France
Facility Name
Groupe Hospitalier Pitié Salpêtrière-Charles Foix
City
Paris
ZIP/Postal Code
75651 cedex 13
Country
France
Facility Name
Groupe Médical de Pneumologie, Polyclinique Saint Laurent
City
Rennes
ZIP/Postal Code
35706
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Hospitalier Universitaire de Tours - Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Pierre-Henri GUILLAUD, MD
City
Vienne
ZIP/Postal Code
38200
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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