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Clinical, physiological and psychosocial determinants of the COPD Assessment Test (CAT).


- candidate number12324
- NTR NumberNTR3416
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mei-2012
- Secondary IDsNL38550.068.11 METC MUMC
- Public TitleClinical, physiological and psychosocial determinants of the COPD Assessment Test (CAT).
- Scientific TitleCorrelates of the COPD Assessment Test (CAT) after stratification for GOLD stages and its response to pulmonary rehabilitation in patients with moderate to very severe COPD.
- ACRONYM
- hypothesis1. (Previously undiagnosed) cardiovascular disease (heart failure/vascular abnormalities/coronary artery disease), metabolic syndrome and other co-morbidities are additional independent predictors of impaired health status, assessed with CAT, in patients with COPD, irrespective of the severity of airflow limitation;
2. CAT is responsive to a comprehensive pulmonary rehabilitation programme in patients with COPD;
3. COPD patients have worse scores on the CAT than healthy elderly subjects;
4. CAT is a valid instrument to assess health status in patients with mild to very severe COPD;
5. CAT scores correlate well with other questionnaires (i.e., SGRQ-C, CCQ).
- Healt Condition(s) or Problem(s) studiedHealth, Chronic Obstructive Pulmonary Disease (COPD), Heart failure
- Inclusion criteria1. Age 40-85 years;
2. COPD patients: Diagnosis of COPD according to GOLD guidelines;
3. Healthy controls: Healthy, as judged by the investigator.
- Exclusion criteria1. History of a significant respiratory disease; having undergone lung surgery; any clinically relevant disease which in the opinion of the investigator may influence the results of the study;
2. Moderate or severe exacerbation or pneumonia requiring systemic corticosteroids, antibiotics or hospitalisation during the last 4 weeks;
3. For healthy controls only: COPD, chronic heart failure.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 25-apr-2012
- planned closingdate1-jul-2014
- Target number of participants950
- InterventionsThere is no intervention. Tertiary care patients will receive a regular pulmonary rehabilitation program which is part of their routine treatment.
- Primary outcomeCAT scores of COPD patients and healthy controls; change in CAT score before and after rehabilitation; correlates of CAT scores (i.e., health status questionnaires, co-morbidity, other potential confounders).
- Secondary outcomeN/A
- TimepointsAll participants have one baseline visit to collect the data of the study. Only tertiary care patients have two visits, one before and one after pulmonary rehabilitation.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Frits Franssen
- CONTACT for SCIENTIFIC QUERIESDr. Frits Franssen
- Sponsor/Initiator CIRO+ (Centre of expertise for chronic organ failure)
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline, Longfonds The Netherlands
- PublicationsN/A
- Brief summaryBackground:
The CAT is a simple eight-item patientcompleted questionnaire and could be used in clinical practice.

Objectives:
Study clinical, physiological and psychosocial determinants of CAT in a broad sample of patients with moderate to very severe COPD and the impact of co-morbidities on health status assessed with CAT; assess the effects of pulmonary rehabilitation on CAT scores in COPD patients; formulate reference values for CAT using healthy controls; validate CAT in a broad sample of COPD patients.

Study design:
Cross sectional observational study with a longitudinal part for tertiary care patients.

Study population:
Broad range of COPD patients (100 COPD patients from primary care setting, 100 COPD patients from secondary care and 600 COPD patients of the tertiary care) between 40 and 85 years old and 150 healthy controls.

Primary study parameters/outcome of the study:
CAT scores of COPD patients and healthy controls; change in CAT score before and after rehabilitation; correlates of CAT scores (i.e., health status questionnaires, co-morbidity, other potential confounders).
- Main changes (audit trail)
- RECORD2-mei-2012 - 10-mei-2012


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