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

This study has been completed.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00879281
First received: April 8, 2009
Last updated: February 23, 2011
Last verified: April 2009
History of Changes
  Purpose

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).


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Behavioral: Action plan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • CCQ-recovery time in the event of an exacerbation(Health status recovery time) [ Time Frame: 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom recovery time in the event of an exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Health Related Quality of Life - St George Respiratory Questionnaire [ Time Frame: baseline and 6 months follow-up ] [ Designated as safety issue: No ]
  • The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: baseline and 6 months follow-up ] [ Designated as safety issue: No ]
  • Medical Research Council (MRC) Dyspnoea Scale [ Time Frame: baseline and 6 months follow-up ] [ Designated as safety issue: No ]
  • Julius Self-Efficacy Scale [ Time Frame: baseline and 6 months follow-up ] [ Designated as safety issue: No ]
  • Contact delay & treatment delay in the event of an exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 233
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879281

Locations
Netherlands
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
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 Katholieke Universiteit Leuven, Belgium
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: A.J.P. Schrijvers, Julius Center for Health Sciences and Primary Care
ClinicalTrials.gov Identifier: NCT00879281     History of Changes
Other Study ID Numbers: OND1333118
Study First Received: April 8, 2009
Last Updated: February 23, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
COPD
emphysema
chronic bronchitis

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013