Predicting the Course of Chronic Obstructive Pulmonary Disease (COPD) in Primary Care (ICECOLDERIC)
| Tracking Information | |||||
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| First Received Date ICMJE | June 25, 2008 | ||||
| Last Updated Date | June 24, 2010 | ||||
| Start Date ICMJE | May 2008 | ||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Chronic Respiratory Questionnaire [ Time Frame: At least 5 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Chronic Respiratory Questionnaire [ Time Frame: At least 2 years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00706602 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Exacerbation [ Time Frame: At least 5 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Exacerbation [ Time Frame: At least 2 years ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Predicting the Course of Chronic Obstructive Pulmonary Disease (COPD) in Primary Care | ||||
| Official Title ICMJE | International Collaborative Effort on Chronic Obstructive Lung Disease: Exacerbation Risk Index Cohorts | ||||
| Brief Summary | Background: COPD is a systemic illness; morbidity and mortality due to this disease are on the increase, and it has great impact on patients' lives. Most COPD patients are managed by general practitioners (GP). GPs base their initial assessment of patients' disease severity mainly on lung function and then inform patients about adequate treatment. However, lung function correlates poorly with COPD-specific health-related quality of life and exacerbation frequency. Preventive cardiology embraced risk index-guided treatment successfully. COPD disease severity indices that better represent the clinical manifestations of COPD are needed that can be used to guide risk-stratified treatment. Objectives: (1) The development and validation of a practical COPD disease severity index to predict the course of health-related quality of life over time. (2) The validation of the ADO-Index (Age, Dyspnea, Obstruction) to predict 3-year mortality in COPD patients in primary care. (3) Link evidence on treatment effects to the COPD risk indices to guide COPD treatment selection. Methods: We are in the process of conducting two linked prospective cohort studies with 413 COPD patients (GOLD stages 2-4) from GPs in Switzerland and the Netherlands. We performed a sound baseline assessment including detailed patient history, lung function, measurement of exercise capacity and blood sampling. During the follow-up of at least five years, we update the patients' profile by registering health status, exacerbations and health-related quality of life and, after 2 years, lung function and measurement of exercise capacity. For aim 1, we will identify the best combination of variables predicting the course of health-related quality of life over time using multivariable regression analysis. For aim 2, we will assess discrimination and calibration of the ADO index to predict 3-year mortality. For aim 3, we will estimate treatment effects for individual patient profiles using complex statistical models such as Markov models. Significance of project: After this study, different risk scores will be available for use in primary care so that general practitioners can estimate what impact COPD will have on the patients. By linking these risk scores to evidence form treatment studies, it will be possible to show for an individual patient how COPD and different treatments impacts on mortality, symptoms and exacerbations. Thereby, patients and physicians can make more informed treatment decisions balancing the benefits and downsides of different treatments. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | COPD patients from primary care. Patients are identified through electronic or paper-based patient charts and by participating general practitioners. |
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| Condition ICMJE | COPD | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Siebeling L, ter Riet G, van der Wal WM, Geskus RB, Zoller M, Muggensturm P, Joleska I, Puhan MA. ICE COLD ERIC--International collaborative effort on chronic obstructive lung disease: exacerbation risk index cohorts--study protocol for an international COPD cohort study. BMC Pulm Med. 2009 May 6;9:15. | ||||
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 450 | ||||
| Estimated Completion Date | August 2014 | ||||
| Estimated Primary Completion Date | August 2014 (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 | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00706602 | ||||
| Other Study ID Numbers ICMJE | 3233B0-115216, 3.4.07.045 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Milo A Puhan/MD PhD, University of Zurich and Johns Hopkins University | ||||
| Study Sponsor ICMJE | University of Zurich | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||
| Verification Date | June 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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