A self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: the COPE-III study protocol

Abstract

Background: Chronic Obstructive Pulmonary Disease (COPD) frequently coexists with other diseases. Whereas COPD action plans are currently part of usual care, they are less suitable and potentially unsafe for use in the presence of comorbidities. This study evaluates whether an innovative treatment approach directed towards COPD and frequently existing comorbidities can reduce COPD exacerbation days. We hypothesise that this approach, which combines self-initiated action plans and nurse support, will accelerate proper treatment actions and lead to better control of deteriorating symptoms.

Methods: In this multicenter randomised controlled trial we aim to include 300 patients with COPD (GOLD II-IV), and with at least one comorbidity (cardiovascular disease, diabetes, anxiety and/or depression). Patients will be recruited from hospitals in the Netherlands (n = 150) and Australia (n = 150) and will be assigned to an intervention or control group. All patients will learn to complete daily symptom diaries for 12-months. Intervention group patients will participate in self-management training sessions to learn the use of individualised action plans for COPD and comorbidities, linked to the diary. The primary outcome is the number of COPD exacerbation days. Secondary outcomes include hospitalisations, quality of life, self-efficacy, adherence, patient's satisfaction and confidence, health care use and cost data.

Analyses: Intention-to-treat analyses (random effect negative binomial regression and random effect mixed models) and cost-effectiveness analyses will be performed.

Discussion: Prudence should be employed before extrapolating the use of COPD specific action plans in patients with comorbidities. This study evaluates the efficacy of tailored action plans for both COPD and common comorbidities.

Keywords: AD; AR-DRG; Australian refined diagnosis related groups; BODE; CAT; CCMP; COPD; COPD Assessment Test; COPD Self-Efficacy Scale; CRQ; CSES; Chronic Obstructive Pulmonary Disease; Chronic Respiratory Questionnaire; Clinical protocols; Comorbidity; Comprehensive Care Management Program; DSMB; Data Safety Monitoring Board; EQ VAS; EQ-5D; ESC; EuroQol Visual Analogue Scale; EuroQol-5 dimensions; European Society of Cardiology; FEV(1); FEV(6); FVC; GOLD; GP; HADS; HL; HbA1c; Health Literacy; Hemoglobin A1c; Hospital Anxiety and Depression Scale; ICFS; Identity-Consequence Fatigue Score; MBS; MMSE; Medicare Benefits Schedule; Mini Mental State Examination; PAS; PBS; Partners in Health; Pharmaceutical Benefit Scheme; PiH; Randomized controlled trial; Research design; SD; Self care; anxiety and/or depression; body mass index, obstruction, dyspnoea, exercise capacity; forced (expiratory) vital capacity; forced expiratory volume in one second; forced expiratory volume in six seconds; general practitioner; global initiative for chronic obstructive lung disease; mMRC; modified Medical Research Council; patient activation status; standard deviation.