Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Randomized Controlled Trial to Establish the (Cost-)Effectiveness of an Interdisciplinary Community-based COPD Management Program Relative to Usual Care.
There is growing evidence that COPD is a multi-organ system disease. Besides impaired lung
function, skeletal muscle weakness and weight loss are important determinants of impaired
exercise performance, decreased quality of life and increased mortality. Based on earlier
succesful intervention studies in pulmonary rehabilitation settings, Máxima Medical Centre
developed an integrated, inter-disciplinary approach to the management of COPD including
physical exercise, nutritional therapy, education, smoking cessation and psychological
consultation. This COPD management program consists of a set of protocols that cover patient
recruitment, diagnostic testing, treatment, follow-up and communication between
professionals.
The exercise program and the nutitional therapy are carried out by local physiotherapists and
dieticians working outside but in conjunction with the hospital. A program in such a setting
could be substantially less expensive and certainly more easily accessible for many more
patients than an inpatient or hospital-based outpatient rehabilitation program, as it is
offered close to a patient's home. This study investigates the (cost-)effectiveness of the
COPD management program compared to usual care in a randomized controlled trial.
Patients with moderate to severe COPD and a reduced exercise capacity during an incremental
exercise test of less than 70% of predicted, are randomised to a treatment or a control
group. The treatment group will participate in the COPD management program during the first 4
months after which they will be followed up for the remaining months. Both groups (n=100) are
followed for 2 years and outcomes will be assessed at the beginning of the program, after 4,
12 and 24 months by disease-specific and generic measures of health status, body composition,
skeletal muscle function and exercise capacity. A cost-effectiveness and cost-utility
analysis with a two-year time horizon will be performed. The analysis is conducted from a
societal perspectice, including the program costs and all COPD-related direct costs within
and outside the healthcare sector ans costs of lost productivity.
n/a
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