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

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: ClinicalTrials.gov NCT00879281.

Figure 1

Schematic overview of the study procedure. Patients are recruited and informed, two weeks before randomization. R: Reinforcement of AP use by telephone, only for the intervention group.

Figure 2

Symptom-based exacerbation algorithm according to Anthonisen et al.

Figure 3

CCQ recovery time. Example of CCQ recovery time in a patient with full recovery (A) and a patient who does not fully recover but has a new baseline (stable) condition after 9 days = 3 units (B).