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

Study Overview
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Brief Summary
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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

Official Title
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Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients

Conditions
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COPD

Intervention / Treatment
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* Device: telemonitoring
* Device: sham telemonitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NIV treatment with telemonitoring<br>telemonitoring is used to manage NIV treatment | Device: telemonitoring<br> <br> * Other names: Easy Care online;|
| Sham Comparator: NIV treatment with sham telemonitoring<br>sham telemonitoring (data not used for NIV management) | Device: sham telemonitoring<br> <br> * Other names: Easy Care online;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIV, COPD, telemonitoring