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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Care as usual | No Intervention | Regular care | |
| 2 Intervention | Experimental | Regular Care + individualized "written" action plan to enhance self-mananagement and early detection/treatment of an exacerbation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Action plan | Behavioral | Individualized "written" Action Plan to enhance self-management and early detection of an exacerbation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CCQ-recovery time in the event of an exacerbation(Health status recovery time) | 6-months |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaap C.A. Trappenburg, MSc | University Medical Center Utrecht, The Netherlands | Principal Investigator |
| 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 Chair |
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht | Utrecht | Utrecht | 3584 CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16235392 | Background | 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. | |
| 17943778 | Background | 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 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 |
| 20040088 | Derived | 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |