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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-18

Study Completion Date

2022-07-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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"Telemonitoring" group

Medical Telemonitoring in Non-Invasive Ventilation

Group Type EXPERIMENTAL

ETAPES Program

Intervention Type 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.

"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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Chronic Care Connect Pneumology Solution

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No