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

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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Action plan

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.

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1 Care as usual; Regular care
Experimental: 2 Intervention; Regular Care + individualized "written" action plan to enhance self-mananagement and early detection/treatment of an exacerbation.	Behavioral: Action plan; Individualized "written" Action Plan to enhance self-management and early detection of an exacerbation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CCQ-recovery time in the event of an exacerbation(Health status recovery time)	6-months

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptom recovery time in the event of an exacerbation	6 months
Health Related Quality of Life - St George Respiratory Questionnaire	baseline and 6 months follow-up
The Hospital Anxiety and Depression Scale (HADS)	baseline and 6 months follow-up
Medical Research Council (MRC) Dyspnoea Scale	baseline and 6 months follow-up
Julius Self-Efficacy Scale	baseline and 6 months follow-up
Contact delay & treatment delay in the event of an exacerbation	6 months
Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year)	6 months
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)	6 months

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: Jaap C.A. Trappenburg, MSc, University Medical Center Utrecht, the Netherlands; Study Chair: Gerdien D. de Weert - van Oene, PhD, University Medical Center Utrecht, the Netherlands; Study Chair: Evelyn M. Monninkhof, PhD, University Medical Center Utrecht, the Netherlands; Study Chair: Thierry Troosters, PhD, KU Leuven; Study Chair: Jean Bourbeau, PhD, McGill University, Montreal Chest Institute, Canada; Study Director: Theo J.M. Verheij, PhD, University Medical Center Utrecht, the Netherlands; Study Director: Jan-Willem J. Lammers, PhD, University Medical Center Utrecht, the Netherlands; Study Director: Guus J.P. Schrijvers, PhD, University Medical Center Utrecht, the Netherlands

Publications and helpful links

General Publications

• 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. doi: 10.1002/14651858.CD002990.pub2.
• 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. doi: 10.1002/14651858.CD005074.pub2.
• Trappenburg JC, Koevoets L, de Weert-van Oene GH, Monninkhof EM, Bourbeau J, Troosters T, Verheij TJ, Lammers JW, Schrijvers AJ. Action Plan to enhance self-management and early detection of exacerbations in COPD patients; a multicenter RCT. BMC Pulm Med. 2009 Dec 29;9:52. doi: 10.1186/1471-2466-9-52.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 8, 2009
• First Submitted That Met QC Criteria: April 8, 2009
• First Posted (Estimate): April 9, 2009

Study Record Updates

• Last Update Posted (Estimate): February 24, 2011
• Last Update Submitted That Met QC Criteria: February 23, 2011
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: COPD; emphysema; chronic bronchitis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: OND1333118