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Open Access Highly Accessed Study protocol

Action Plan to enhance self-management and early detection of exacerbations in COPD patients; a multicenter RCT

Jaap CA Trappenburg1*, Lieselotte Koevoets1, Gerdien H de Weert-van Oene1, Evelyn M Monninkhof1, Jean Bourbeau2, Thierry Troosters3, Theo JM Verheij1, Jan-Willem J Lammers4 and Augustinus JP Schrijvers1

Author Affiliations

1 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands

2 , Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University, 3650 St. Urbain Street, Montreal, Canada

3 , Department of Rehabilitation and Respiratory Division, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, B-3000 Leuven, Belgium

4 Department of Respiratory Medicine, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands

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BMC Pulmonary Medicine 2009, 9:52  doi:10.1186/1471-2466-9-52

Published: 29 December 2009

Abstract

Background

Early detection of exacerbations by COPD patients initiating prompt interventions has shown to be clinically relevant. Until now, research failed to identify the effectiveness of a written individualized Action Plan (AP) to achieve this.

Methods/Design

The current multicenter, single-blind RCT with a follow-up period of 6 months, evaluates the hypothesis that individualized AP's reduce exacerbation recovery time. Patients are included from regular respiratory nurse clinics and allocated to either usual care or the AP intervention. The AP provides individualized treatment prescriptions (pharmaceutical and non-pharmaceutical) related to a color coded symptom status (reinforcement at 1 and 4 months). Although usually not possible in self-management trials, we ensured blinding of patients, using a modified informed consent procedure in which patients give consent to postponed information. Exacerbations in both study arms are defined using the Anthonisen symptom diary-card algorithm. The Clinical COPD Questionnaire (CCQ) is assessed every 3-days. CCQ-recovery time of an exacerbation is the primary study outcome. Additionally, healthcare utilization, anxiety, depression, treatment delay, and self-efficacy are assessed at baseline and 6 months. We aim at including 245 COPD patients from 7 hospitals and 5 general practices to capture the a-priori sample size of at least 73 exacerbations per study arm.

Discussion

This RCT identifies if an AP is an effective component of self-management in patients with COPD and clearly differentiates from existing studies in its design, outcome measures and generalizability of the results considering that the study is carried out in multiple sites including general practices.

Trial Registration

NCT00879281