Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Adherence to Medication and Its Impact on COPD Exacerbations: The AMICE Prospective Study
Chronic Obstructive Pulmonary Disease (COPD) represents one of the most challenging chronic
diseases of the 21st century: it is expected to be the fourth leading cause of death by
2030. COPD is characterized by pulmonary and extra-pulmonary systemic manifestations caused
by partly irreversible expiratory airflow obstruction. The cornerstone of COPD management is
the prescription of single or combined inhalation therapy, such as short- and long-acting
bronchodilators, inhaled corticosteroids to possibly prevent disease progression, preserve
lung function, relieve respiratory symptoms and prevent or treat exacerbations. Given the
complex and lifelong treatment, one can expect that adherence to the prescribed inhalation
therapy is not self-evident. Adherence can be defined as the "the extent to which a person's
behaviour (taking medications, following a recommended diet and/or executing life-style
changes) corresponds with the agreed recommendations of a health care provider". Inhaled
medications have an additional complexity in that patients who intend to be adherent may be
take the inhaled medication incorrectly, prohibiting proper therapeutic action. Taking less
than the prescribed amount of medication, missing doses or stopping treatment for brief or
extended periods will put the patient at risk for suboptimal disease control. Hence, the
effectiveness will largely depend on the patient's ability to manage their disease
adequately in daily life.
Using electronic monitoring, 3 studies in COPD found a prevalence of medication
non-adherence of 51% which was worse than the average prevalence of 29% (range 3-66%) found
across diseases such as hypertension, cancer, epilepsia, infections and HIV.
The existing evidence on risk factors for nonadherence in COPD is mostly anecdotic and not
guided by behavioral models. According to the integrated model of behavioral prediction
(IMBP), barriers, skills and ability and intention are the most important drivers of
adherence (i.e. medication adherence).
The aims of the study are the following:
- To prospectively investigate the impact of medication nonadherence on time to
exacerbation (primary end-point) and exacerbation rate, FEV1, hospitalization rate and
duration, and quality of life (secondary end-points) at 1 year follow-up using
electronic monitoring
- To investigate risk factors for medication nonadherence, using the Integrated Model of
Behavioral Prediction as a theoretical framework
- To determine the diagnostic accuracy of different measures of medication nonadherence
(i.e. pill count, self-report and physician rating) relative to electronic monitoring.
- To investigate the prevalence of nonadherence to other aspects of the therapeutic
regimen, i.e. the use of concomitant medications, smoking cessation, alcohol use,
physical activity, attendance to rehabilitation sessions and dietary adherence, their
interrelations, and impact (alone and in combination) on time to first exacerbation.
- To investigate the interrelations in adherence to the various components of the
therapeutic regimen.
- To investigate the impact of nonadherence to the other components of the therapeutic
regimen (alone and in combination) on clinical outcomes (i.e. time to exacerbation,
exacerbation rate/PPY, FEV1, hospitalization rate and duration, and quality of life at
1 year follow-up.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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