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Randomized Controlled Trial
. 2016 Jun 28:11:1447-51.
doi: 10.2147/COPD.S107151. eCollection 2016.

An international randomized study of a home-based self-management program for severe COPD: the COMET

Jean Bourbeau  1 , Pere Casan  2 , Silvia Tognella  3 , Peter Haidl  4 , Joëlle B Texereau  5 , Romain Kessler  6
Affiliations
Randomized Controlled Trial

An international randomized study of a home-based self-management program for severe COPD: the COMET

Jean Bourbeau et al. Int J Chron Obstruct Pulmon Dis. .

Abstract

Introduction: Most hospitalizations and costs related to COPD are due to exacerbations and insufficient disease management. The COPD patient Management European Trial (COMET) is investigating a home-based multicomponent COPD self-management program designed to reduce exacerbations and hospital admissions.

Design: Multicenter parallel randomized controlled, open-label superiority trial.

Setting: Thirty-three hospitals in four European countries.

Participants: A total of 345 patients with Global initiative for chronic Obstructive Lung Disease III/IV COPD.

Intervention: The program includes extensive patient coaching by health care professionals to improve self-management (eg, develop skills to better manage their disease), an e-health platform for reporting frequent health status updates, rapid intervention when necessary, and oxygen therapy monitoring. Comparator is the usual management as per the center's routine practice.

Main outcome measures: Yearly number of hospital days for acute care, exacerbation number, quality of life, deaths, and costs.

Keywords: COPD; clinical trial; disease management; exacerbations; home care; hospitalization.

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Figures

Figure 1
Figure 1
Design of the COMET study. Notes: COPD patients are randomized 1:1 into a home-based management group and a comparison group. Following patient education, the home-based management group provides proactive health status updates weekly or in cases of symptom worsening. Patients reporting worsening or alarm status receive a telephone call by a CM and confirmed cases of alarm status are referred to the investigator for same-day medical assessment and management. Outcomes will be analyzed after all patients have completed their follow-up period of 2 years (maximum) and the study is complete. Abbreviations: CM, case manager; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; QOL, quality of life; BODE, body mass index, airflow obstruction, dyspnea, and exercise capacity; AE, adverse events; COMET, COPD patient Management European Trial.
See this image and copyright information in PMC

References

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