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 journalArticleAcademicpeer-review

16 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
JournalContemporary clinical trials
Volume36
Issue number1
DOIs
Publication statusPublished - 2013

Fingerprint

Self Care
Chronic Obstructive Pulmonary Disease
Comorbidity
Nurses
Disease Progression
Obstructive Lung Diseases
N-succinyl-1,2-dioleoylphosphatidylethanolamine
Self Efficacy
Patient Satisfaction
Health Care Costs
Netherlands
Cost-Benefit Analysis
Hospitalization
Cardiovascular Diseases
Anxiety
Randomized Controlled Trials
Quality of Life
Depression
Control Groups
Therapeutics

Keywords

  • IR-88483
  • METIS-300349

Cite this

@article{ff2a919da01845148d3814f08ac5a4c8,
title = "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 = "IR-88483, METIS-300349",
author = "Anke Lenferink and Peter Frith and {van der Valk}, Paul and Julie Buckman and Ruth Sladek and Paul Cafarella and {van der Palen}, Job and Tanja Effing",
year = "2013",
doi = "10.1016/j.cct.2013.06.003",
language = "English",
volume = "36",
pages = "81--89",
journal = "Contemporary clinical trials",
issn = "1551-7144",
publisher = "Elsevier",
number = "1",

}

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

In: Contemporary clinical trials, Vol. 36, No. 1, 2013, p. 81-89.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - 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

AU - Lenferink, Anke

AU - Frith, Peter

AU - van der Valk, Paul

AU - Buckman, Julie

AU - Sladek, Ruth

AU - Cafarella, Paul

AU - van der Palen, Job

AU - Effing, Tanja

PY - 2013

Y1 - 2013

N2 - 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.

AB - 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.

KW - IR-88483

KW - METIS-300349

U2 - 10.1016/j.cct.2013.06.003

DO - 10.1016/j.cct.2013.06.003

M3 - Article

VL - 36

SP - 81

EP - 89

JO - Contemporary clinical trials

JF - Contemporary clinical trials

SN - 1551-7144

IS - 1

ER -