Early detection of exacerbations by COPD patients allows them to initiate prompt interventions; the approach has been shown to be clinically relevant. Until now, however, research has failed to identify the effectiveness of a written individualized Action Plan (AP) to achieve this aim. A multicenter, single blind randomized control trial (RCT) with a follow-up period of 6 months is permitting Trappenburg and colleagues to evaluate 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, blinding of patients is occurring by 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. In addition, healthcare utilization, anxiety, depression, treatment delay, and self-efficacy will be assessed at baseline and 6 months. The investigators hope to recruit 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.

WHAT THE STUDY MAY MEAN TO YOU AS A HEALTH CARE PROVIDER. The authors predict that the RCT identifies if an AP is an effective component of self-management in patients with COPD. The study should clearly differentiate 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.

WHAT THE STUDY MAY MEAN TO YOU AS A PATIENT: Self-management of COPD has lagged behind research on other respiratory disorders, particularly asthma. However, studies such as this trial with COPD patients could rapidly narrow the gap.

JC Trappenburg et al. Action Plan to enhance self-management and early detection of exacerbations in COPD patients; a multicenter RCT. BMC Pulmonary Medicine, 2009;9:52.