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

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ClinicalTrials.gov Identifier: NCT00879281
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:
UMC Utrecht

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Behavioral: Action plan Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)
Study Start Date : December 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. CCQ-recovery time in the event of an exacerbation(Health status recovery time) [ Time Frame: 6-months ]

Secondary Outcome Measures :
  1. Symptom recovery time in the event of an exacerbation [ Time Frame: 6 months ]
  2. Health Related Quality of Life - St George Respiratory Questionnaire [ Time Frame: baseline and 6 months follow-up ]
  3. The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: baseline and 6 months follow-up ]
  4. Medical Research Council (MRC) Dyspnoea Scale [ Time Frame: baseline and 6 months follow-up ]
  5. Julius Self-Efficacy Scale [ Time Frame: baseline and 6 months follow-up ]
  6. Contact delay & treatment delay in the event of an exacerbation [ Time Frame: 6 months ]
  7. Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year) [ Time Frame: 6 months ]
  8. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879281


Locations
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Netherlands
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
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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
More Information
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Publications:

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

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Responsible Party: A.J.P. Schrijvers, Julius Center for Health Sciences and Primary Care
ClinicalTrials.gov Identifier: NCT00879281    
Other Study ID Numbers: OND1333118
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: April 2009
Keywords provided by UMC Utrecht:
COPD
emphysema
chronic bronchitis
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases