|- candidate number||12324|
|- NTR Number||NTR3416|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-mei-2012|
|- Secondary IDs||NL38550.068.11 METC MUMC|
|- Public Title||Clinical, physiological and psychosocial determinants of the COPD Assessment Test (CAT).|
|- Scientific Title||Correlates 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.|
|- hypothesis||1. (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) studied||Health, Chronic Obstructive Pulmonary Disease (COPD), Heart failure|
|- Inclusion criteria||1. Age 40-85 years;|
2. COPD patients: Diagnosis of COPD according to GOLD guidelines;
3. Healthy controls: Healthy, as judged by the investigator.
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||25-apr-2012|
|- planned closingdate||1-jul-2014|
|- Target number of participants||950|
|- Interventions||There is no intervention. Tertiary care patients will receive a regular pulmonary rehabilitation program which is part of their routine treatment.|
|- Primary outcome||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).|
|- Secondary outcome||N/A|
|- Timepoints||All 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 site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Frits Franssen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Frits Franssen|
|- Sponsor/Initiator ||CIRO+ (Centre of expertise for chronic organ failure)|
(Source(s) of Monetary or Material Support)
|GlaxoSmithKline, Longfonds The Netherlands |
|- Brief summary||Background: |
The CAT is a simple eight-item patientcompleted questionnaire and could be used in clinical practice.
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.
Cross sectional observational study with a longitudinal part for tertiary care patients.
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)|
|- RECORD||2-mei-2012 - 10-mei-2012|