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Action Plan to Enhance Self-management and Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients

Information source: UMC Utrecht
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Action plan (Behavioral)

Phase: N/A

Status: Completed

Sponsored by: UMC Utrecht

Official(s) and/or principal investigator(s):
Jaap C.A. Trappenburg, MSc, Principal Investigator, Affiliation: University Medical Center Utrecht, The Netherlands
Gerdien D. de Weert - van Oene, PhD, Study Chair, Affiliation: University Medical Center Utrecht, The Netherlands
Evelyn M. Monninkhof, PhD, Study Chair, Affiliation: University Medical Center Utrecht, The Netherlands
Thierry Troosters, PhD, Study Chair, Affiliation: Katholieke Universiteit Leuven, Belgium
Jean Bourbeau, PhD, Study Chair, Affiliation: McGill University, Montreal Chest Institute, Canada
Theo J.M. Verheij, PhD, Study Director, Affiliation: University Medical Center Utrecht, The Netherlands
Jan-Willem J. Lammers, PhD, Study Director, Affiliation: University Medical Center Utrecht, The Netherlands
Guus J.P. Schrijvers, PhD, Study Director, Affiliation: University Medical Center Utrecht, The Netherlands

Summary

The purpose of this randomized controlled trial is to evaluate the hypothesis that the 'written' action plan, a self-management tool developed by the project group, enhances early detection and prompt action measures and consequently isbeneficial in exacerbation outcome (i. e., health status recovery time).

Clinical Details

Official title: Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: CCQ-recovery time in the event of an exacerbation(Health status recovery time)

Secondary outcome:

Symptom recovery time in the event of an exacerbation

Health Related Quality of Life - St George Respiratory Questionnaire

The Hospital Anxiety and Depression Scale (HADS)

Medical Research Council (MRC) Dyspnoea Scale

Julius Self-Efficacy Scale

Contact delay & treatment delay in the event of an exacerbation

Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year)

Healthcare Utilization (The number of respiratory-related hospital admissions, hospital days, emergency room visits and scheduled and unscheduled visits or telephone calls to a RP and GP)

Detailed description: 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. 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 visits and allocated to either usual care or an additional AP providing individualized treatment prescriptions (pharmaceutical and non-pharmaceutical) related to a colour 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 our primary outcome. Additionally, healthcare utilisation, anxiety, depression, treatment delay, and self-efficacy are assessed at baseline, 6 and 12 months.

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- post-bronchodilator forced expiratory volume in 1 second/forced vital capacity

(FEV1/FVC) ratio < 70%

- age > 40 years

- complaints of chronic cough

- smoking history of more than 20 years or 15 pack-years

- diagnosis of COPD as major functionally limiting disease and

- current use of bronchodilator therapy.

Exclusion Criteria:

- primary diagnosis of asthma

- primary diagnosis of cardiac disease

- presence of disease that could either effect mortality or participation in the study

(e. g. confusional states).

Locations and Contacts

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht 3584 CX, Netherlands
Additional Information

Related publications:

Turnock AC, Walters EH, Walters JA, Wood-Baker R. Action plans for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD005074. Review. Update in: Cochrane Database Syst Rev. 2010;(5):CD005074.

Effing T, Monninkhof EM, van der Valk PD, van der Palen J, van Herwaarden CL, Partidge MR, Walters EH, Zielhuis GA. Self-management education for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD002990. Review. Update in: Cochrane Database Syst Rev. 2014;3:CD002990.

Starting date: December 2008
Last updated: February 23, 2011

Page last updated: August 23, 2015

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