Exacerbations and Health Related Quality of Life in Chronic Obstructive Pulmonary Disease
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 20, 2009 | ||||
| Last Updated Date | April 20, 2009 | ||||
| Start Date ICMJE | May 2002 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Exacerbations and Health Related Quality of Life in Chronic Obstructive Pulmonary Disease | ||||
| Official Title ICMJE | Exacerbations and Health Related Quality of Life in Chronic Obstructive Pulmonary Disease: CRECOPD Study | ||||
| Brief Summary | Chronic obstructive pulmonary disease (COPD) exacerbation is a major cause of physician visits and hospital admissions associated with acute respiratory failure, causing increased morbidity and premature mortality and thus it can significantly affect Health Related Quality of Life (HRQoL). Previous studies suggested that patients who have experienced frequent exacerbation present worse HRQoL compared to patients with infrequent exacerbations. However, there are still questions regarding the relationship between HRQoL and exacerbations. In the present study the investigators will study a cohort of COPD patients over 6 years, they will document exacerbations, they will assess lung emphysema by computed tomography of the chest and they will evaluate health related quality of life in COPD patients. The investigators hypothesize that the extend of emphysema in COPD patients is positively correlated with worsen Health related quality of life (HRQoL). |
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| Detailed Description | Chronic obstructive pulmonary disease (COPD) is characterized by progressive loss of lung function and recurrent exacerbations. COPD exacerbation is a major cause of physician visits and hospital admissions associated with acute respiratory failure, causing increased morbidity and premature mortality and thus it can significantly affect HRQoL. Previous studies suggested that patients who have experienced frequent exacerbation present worse HRQoL compared to patients with infrequent exacerbations. However, there are still questions regarding the relationship between HRQoL and exacerbations. Only few studies which are not an integral part of a clinical trial investigated the relationship between exacerbations and long-term impairment of HRQoL. Furthermore, a recent study failed to show that exacerbations remain a significant determinant of HRQoL when several other prognostic factors were taken into account. In addition, there is luck of data regarding differences in HRQoL between patients with different phenotypes (i.e., emphysema or chronic bronchitis predominance). In this respect we prospectively study the long term effect of exacerbations on the quality of life of patients with COPD and we aim to investigate further the relationship between exacerbations and HRQoL. The investigators hypothesize that the extend of emphysema is positively correlated with worsen Health related quality of life (HRQoL). Consecutive sampling will be used to recruit patients with a diagnosis of COPD according to the GOLD definition.Exacerbations will be identified as worsening of patient's respiratory signs as recorded on diary cards. HQoL will be assessed using the Saint George Respiratory Questionaire (SGRQ). Patients will undergo high resolution computed tomography of the chest(HRCT). Multiple linear regression analysis will be used to identify factors which explain SGRQ deterioration over the study period for the entire population and for smokers and ex-smokers separately. |
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| 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 | Patients with a diagnosis of Chronic Obstructive Lung Disease according to the GOLD definition (Pauwels RA, Buist AS, Calverley PM, et al; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med. 2001;163(5):1256-76.), who attend outpatient clinics at Chania General Hospital on the island of Crete, Greece |
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| Condition ICMJE | Chronic Obstructive Pulmonary Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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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 | ||||
| Enrollment ICMJE | 102 | ||||
| Estimated Completion Date | June 2009 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00884975 | ||||
| Other Study ID Numbers ICMJE | DM19021970DM | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Demosthenes Makris, University of Thessaly | ||||
| Study Sponsor ICMJE | University of Thessaly | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Thessaly | ||||
| Verification Date | April 2009 | ||||
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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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