Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients (eCOPD)

Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.

Multicentric Randomized Controlled Trial

Primary Objective:

To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term treatment efficacy and patient compliance

Secondary Objectives:

To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with NIV

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: telemonitoring; Device: sham telemonitoring

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Hopital Privé La Louviere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• COPD patient already treated by NIV requiring therapy assessment in their routine care Follow-Up or
• COPD patient requiring de Novo NIV therapy according to routine care rules (NIV<12h)
• Patient requiring NIV therapy by S9 VPAP ST +/- oxygen therapy
• Patient willing to participate to the study
• Patient or attendant able to complete patient passport and to come to Follow-Up visits.

Exclusion Criteria:

• NIV therapy Failure during screening phase (intolerance, patient refusal, significant leaks, significant AHI or Oxymetry events)
• Hospitalization conducting to NIV discontinuation for at least 1 week during the screening phase

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NIV treatment with telemonitoring; telemonitoring is used to manage NIV treatment	Device: telemonitoring; Other Names: Easy Care online
Sham Comparator: NIV treatment with sham telemonitoring; sham telemonitoring (data not used for NIV management)	Device: sham telemonitoring; Other Names: Easy Care online

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood Gaz and nocturnal transcutaneous carbon dioxyde partial pressure (PtCO2) evolution	12 months
Compliance evolution: mean duration usage (hour per day)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Non-Intentional leaks	12 months
Peripheral oxygen saturation (SP02)	12 months
Apnea Hypopnea Index (AHI)	12 months
Oxygen desaturation Index (ODI)	12 months
Time with peripheral oxygen saturation (SP02) < 90%	12 months
St Georges Quality of Life questionnaire	12 months
6 Minutes Walking Test (6MWT)	12 months
The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity - (BODE) Index	12 months
Epworth Sleepiness Scale (ESS)	12 months
% of patients with Ventilatory asynchronisms	12 months
Mean Noninvasive Ventilation (NIV) use duration (hour/day)	12 months
% of days with noninvasive Ventilation (NIV) use ≥ 4h/day	12 months
% of days with noninvasive Ventilation (NIV) use < 4h/day	12 months
% of days with no Noninvasive Ventilation (NIV) use	12 months

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Thibaut Gentina, MD, Hôpital Privé la Louvière - Lille

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: September 24, 2014
• First Submitted That Met QC Criteria: October 2, 2014
• First Posted (Estimate): October 7, 2014

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: COPD; NIV; telemonitoring
• Other Study ID Numbers: eCOPD 001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No