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

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ResMed

Status

Completed

Conditions

COPD

Treatments

Device: sham telemonitoring
Device: telemonitoring

Study type

Interventional

Funder types

Industry

Identifiers

NCT02258191
eCOPD 001

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

NIV treatment with telemonitoring
Active Comparator group
Description:
telemonitoring is used to manage NIV treatment
Treatment:
Device: telemonitoring
NIV treatment with sham telemonitoring
Sham Comparator group
Description:
sham telemonitoring (data not used for NIV management)
Treatment:
Device: sham telemonitoring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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