The development of a practical COPD disease severity index developed and validated in primary care settings and thus ready-for-use in primary care after completion of the proposed project.
ID
Source
Brief title
Condition
- Other condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Health condition
Experts currently see COPD as a systemic illness, not just as a pulmonary illness
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Exacerbations and health-related quality of life
Secondary outcome
not applicable
Background summary
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 the presence of airway
symptoms, and then advise on adequate treatment. However, FEV1 and clinical
symptoms correlate poorly with exacerbation frequency and/or health-related
quality of life. Preventive cardiology embraced risk index-guided treatment
successfully. Now, the European Respiratory Society (ERS) and American Thoracic
Society (ATS) call for a COPD disease severity index that better represents the
clinical manifestations of COPD.
Study objective
The development of a practical COPD disease severity index developed and
validated in primary care settings and thus ready-for-use in primary care after
completion of the proposed project.
Study design
We will conduct three linked prospective cohort studies with COPD patients
(GOLD stages 2-4) from GPs in Switzerland, the Netherlands and, at a later
stage, Canada. We will perform an extensive baseline assessment including
detailed patient history, lung function, measurement of exercise capacity and
blood sampling. During the follow-up of at least two years, we update the
patients* profile by registering health status, exacerbations and
health-related quality of life. Using multivariable regression analysis we will
identify the best combination of variables predicting the course of
health-related quality of life.
Study burden and risks
At baseline: single visit to nearby general practice for venepuncture (once,
40ml) and lung function test (before and after bronchodilation using a inhaled
beta-2 adrenergic drug), questionnaires, two short exercise tests,
Follow-up: annually one 30-minute telephone interview (2 times, 5 times if
further funding is acquired).
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients *40 years of age with COPD in GOLD stage II to IV (postbronchodilator FEV1/FVC*0.70, postbronchodilator FEV1*80% predicted are eligible if in- or outpatient treatment of their last exacerbation ended *4 weeks ago. If patients had an exacerbation in the previous 4 weeks, (s)he can be invited when free of exacerbations for at least 4 weeks. We will include any patient who is able to complete the baseline assessment.
Exclusion criteria
We will exclude patients who received mechanical ventilation in the previous 12 months because of their extremely poor prognosis and patients with co-morbidities associated with a life expectancy of *12 months. We will also exclude patients diagnosed with dementia, psychosis or other psychiatric illness that invalidate assessment of patient-reported parameters (health-related quality of life, physical activity, dyspnea etc). Finally, we will exclude patients if the baseline assessment including the questionnaires cannot be completed due to language difficulties.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22118.018.08 |