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

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

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

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
Netherlands | |
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht | |
Utrecht, Netherlands, 3584 CX |
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 | |
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:
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 |
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:
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |