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

Anke Lenferink, Peter Frith, Paul van der Valk, Julie Buckman, Ruth Sladek, Paul Cafarella, Job van der Palen, Tanja Effing

    Research output: Contribution to journalArticle

    17 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)81-89
    Number of pages9
    JournalContemporary Clinical Trials
    Volume36
    Issue number1
    DOIs
    Publication statusPublished - Sep 2013

    Keywords

    • Chronic Obstructive Pulmonary Disease
    • Clinical protocols
    • Comorbidity
    • Randomized controlled trial
    • Research design
    • Self care

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