Action Plan to Enhance Self-management and Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients (ACZiE)
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First Received Date ICMJE | April 8, 2009 | ||||||||||||||||||||||||||||||||
Last Updated Date | February 23, 2011 | ||||||||||||||||||||||||||||||||
Start Date ICMJE | December 2008 | ||||||||||||||||||||||||||||||||
Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
CCQ-recovery time in the event of an exacerbation(Health status recovery time) [ Time Frame: 6-months ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||
Change History | Complete list of historical versions of study NCT00879281 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||||||||||||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||||||||||
Brief Title ICMJE | Action Plan to Enhance Self-management and Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients | ||||||||||||||||||||||||||||||||
Official Title ICMJE | Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE) | ||||||||||||||||||||||||||||||||
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). |
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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. |
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Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||
Study Phase | |||||||||||||||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Obstructive Pulmonary Disease | ||||||||||||||||||||||||||||||||
Intervention ICMJE | Behavioral: Action plan
Individualized "written" Action Plan to enhance self-management and early detection of an exacerbation. |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||||||||||
Enrollment ICMJE | 233 | ||||||||||||||||||||||||||||||||
Completion Date | December 2010 | ||||||||||||||||||||||||||||||||
Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||||||||||||||||||||||
Ages | 40 Years and older | ||||||||||||||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||
Location Countries ICMJE | Netherlands | ||||||||||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||||||||||
NCT Number ICMJE | NCT00879281 | ||||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | OND1333118 | ||||||||||||||||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||||||||||||||||
Responsible Party | A.J.P. Schrijvers, Julius Center for Health Sciences and Primary Care | ||||||||||||||||||||||||||||||||
Study Sponsor ICMJE | UMC Utrecht | ||||||||||||||||||||||||||||||||
Collaborators ICMJE | |||||||||||||||||||||||||||||||||
Investigators ICMJE |
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Information Provided By | UMC Utrecht | ||||||||||||||||||||||||||||||||
Verification Date | April 2009 | ||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |