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The COPD Patient Management European Trial (COMET)

NCT01241526 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2016-01-14

No results posted yet for this study

Summary

The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.

By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

OTHER

Disease Management

* Individual, group and phone education sessions * Telephone supporter follow-up * LTOT monitoring

OTHER

Usual site management

* Usual education as per site protocol * Usual follow-up as per site protocol * LTOT monitoring

Sponsors & Collaborators

  • ITEC Services

    collaborator OTHER

  • Lincoln Medical and Mental Health Center

    collaborator OTHER

  • Air Liquide Santé International

    lead INDUSTRY

Principal Investigators

  • Romain KESSLER, MD · Hopital Civil de Strasbourg - France

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-02-28
Completion
2015-10-31

Countries

  • France
  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01241526 on ClinicalTrials.gov