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.
RCT Entities:
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.
Authors: Anke Lenferink; Marjolein Brusse-Keizer; Paul Dlpm van der Valk; Peter A Frith; Marlies Zwerink; Evelyn M Monninkhof; Job van der Palen; Tanja W Effing Journal: Cochrane Database Syst Rev Date: 2017-08-04
Authors: Tanja W Effing; Anke Lenferink; Julie Buckman; Deborah Spicer; Paul A Cafarella; Morton G Burt; Katherine L Bassett; Clara van Ommeren; Sally Anesbury; Paul D L P M van der Valk; Peter A Frith; Job van der Palen Journal: J Thorac Dis Date: 2014-11 Impact factor: 2.895
Authors: Charlotte C Poot; Eline Meijer; Annemarije L Kruis; Nynke Smidt; Niels H Chavannes; Persijn J Honkoop Journal: Cochrane Database Syst Rev Date: 2021-09-08
Authors: Jade Schrijver; Anke Lenferink; Marjolein Brusse-Keizer; Marlies Zwerink; Paul Dlpm van der Valk; Job van der Palen; Tanja W Effing Journal: Cochrane Database Syst Rev Date: 2022-01-10
Authors: Anke Lenferink; Tanja Effing; Peter Harvey; Malcolm Battersby; Peter Frith; Wendy van Beurden; Job van der Palen; Muirne C S Paap Journal: PLoS One Date: 2016-08-26 Impact factor: 3.240
Authors: Emma J Dennett; Sadia Janjua; Elizabeth Stovold; Samantha L Harrison; Melissa J McDonnell; Anne E Holland Journal: Cochrane Database Syst Rev Date: 2021-07-26