The main objective of this study is the 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 the HRQL assessed with CAT. Secondary objectives…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the CAT scores of the COPD patients and the
healthy controls. With the CAT scores we can examine the absolute and percent
difference between COPD patients based on severity of their COPD. Also the
absolute and percent difference between COPD patients and healthy controls
shall be examined. For the tertiary care patients is the change in CAT score
before and after rehabilitation important. CAT scores shall also be correlated
with existing HRQL questionnaires, co-morbidity, and other potential
confounders.
Secondary outcome
not applicable.
Background summary
The prevalence of patients with Chronic Obstructive Pulmonary Disease (COPD) is
expected to increase. The Healthy Related Quality of Life (HRQL) of COPD
patients is impaired, but the assessment of HRQL is time consuming and have
complex scoring algorithms for daily practice. The COPD assessment test (CAT)
is a simple eight-item patient-completed questionnaire and could be used in
clinical practice. Limited information is available about the correlates of
clinical physiological and psychological characteristics of COPD patients with
CAT. The hypotheses of this study are:
a. (previously undiagnosed) cardiovascular disease and other co-morbidities are
additional independent predictors of impaired health status, assessed with CAT,
in patients with COPD
b. CAT is responsive to a comprehensive pulmonary rehabilitation programme in
patients with COPD.
c. COPD patients have worse scores on the CAT than healthy elderly subjects
d. CAT is a valid instrument to assess health status in patients with mild to
very severe COPD.
Study objective
The main objective of this study is the 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 the HRQL assessed with
CAT. Secondary objectives are to assess the effects of pulmonary rehabilitation
on CAT scores in COPD patients, to formulate reference values for CAT using
healthy controls and validate CAT in a broad sample of COPD patients.
Study design
This study is a cross sectional observational study with a longitudinal part
for tertiary care patients.
Study burden and risks
All participants have one baseline visit to collect the data of the study.
Besides the CAT medical history and physical examination, 4 other
questionnaires, lung function, body composition, daily physical functioning
test and saturation shall be assessed. Only the patients of the tertiary care
have two visits, one before and one after pulmonary rehabilitation. Also the
number of tests for tertiary care patients is higher but these test are part of
the regular pulmonary rehabilitation assessment. The tests can cause fatigue
for the participants but are used in daily clinical practice. Therefore no
additional risks were expected for the participants.
Hornerheide 1
Horn 6085 NM
NL
Hornerheide 1
Horn 6085 NM
NL
Listed location countries
Age
Inclusion criteria
1. Age 40-85 years
2. A diagnosis of COPD according to GOLD guidelines only applicable for COPD patients
3. Referral for assessment and pulmonary rehabilitation in Ciro+ by a chest physician only applicable for tertiary care patients.
4. Healthy, as judged by the investigator and determined by medical history and physical examination and post-bronchodilator FEV1/FVC * 70 only applicable for healthy controls
Exclusion criteria
1. For healthy controls, primary, secondary and tertiary care patients: a history of asthma, kung cancer, sarcoidosis, tuberculosis, lung fibrosis, or any other significant respiratory disease; having undergone lung surgery (e.g. lung volume reduction, lung transplantation); any clinically relevant disease which in the opinion of the investigator may influence the results of the study
2. For primary, secondary and tertiary care patients only: moderate or severe exacerbation or pneumonia requiring systemic corticosteroids, antibiotics or hospitalisation during the last 4 weeks
3. For health controls only: COPD, chronic heart failure
4. Treatment by respiratory physician or tertiary care in primary care COPD patients
5. Treatment in tertiary care setting for secondary care COPD patients
6. Participation in an interventional clinical study during the past three months (for primary and secondary care patients).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | Nederlands Trial Register: NTR3416 |
| CCMO | NL38550.068.11 |
| OMON | NL-OMON21987 |