Adherence to Medication and Its Impact on Chronic Obstructive Pulmonary Disease (COPD) Exacerbations: The AMICE Prospective Study (AMICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01293890
Recruitment Status : Unknown
Verified July 2013 by Marc Decramer, KU Leuven.
Recruitment status was:  Recruiting
First Posted : February 11, 2011
Last Update Posted : July 30, 2013
Boehringer Ingelheim
Information provided by (Responsible Party):
Marc Decramer, KU Leuven

Brief Summary:

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.

Condition or disease
Chronic Obstructive Pulmonary Disease

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adherence to Medication and Its Impact on COPD Exacerbations: The AMICE Prospective Study
Study Start Date : March 2011
Estimated Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

COPD patients with hospital admission for exacerbation

Primary Outcome Measures :
  1. time to exacerbation [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. exacerbation rate [ Time Frame: 1 year ]
  2. Forced expiratory volume in one second (FEV1) [ Time Frame: 1 year ]
  3. Number of hospitalization rate due to exacerbations [ Time Frame: 1 year ]
  4. Duration of hospitalizations due to exacerbations [ Time Frame: 1 year ]
  5. Functional status [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
blood urine

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients that are admitted to the Pneumology of Geriatry Service of UZ Leuven after entering the emercency ward with a COPD exacerbation

Inclusion Criteria:

  • Clinical diagnosis of COPD
  • Age > 40 years old
  • Documented spirometry within the last 12 months with a post-bronchodilator FEV1 < 80% of predicted and an FEV1 < 70% of FVC (4 puffs of salbutamol 30 minutes prior to spirometry)
  • Patients being hospitalized for an exacerbation at the University Hospitals of Leuven at time of enrollment
  • Patients currently treated with Spiriva for at least 4 weeks at the start of the data collection (i.e. 4 weeks after hospitalization for an exacerbation)
  • Oral fluency in Dutch
  • Being capable to provide informed consent

Exclusion Criteria:

  • A documented history of asthma or another respiratory disease
  • An expected life expectancy of < 6 months
  • Cognitive impairment (Mini Mental State Examination test results < 25) or presence of other co-morbidities preventing patients from completing the self-report instruments and/or using electronic monitoring
  • Institutionalized patients, patients living in a nursing home or patients not managing their medications independently

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01293890

Contact: Marc Decramer, MD, PhD 3216346800
Contact: Janssens Wim, MD, PhD 016/340 957

University Hospital Leuven Recruiting
Leuven, Flanders, Belgium, 3000
Principal Investigator: Marc Decramer, MD, PhD         
Sub-Investigator: Wim Janssens, MD, PhD         
Sub-Investigator: Fabienne Dobbels, PhD         
Sub-Investigator: Troosters Thierry, PhD         
Sponsors and Collaborators
KU Leuven
Boehringer Ingelheim
Principal Investigator: Marc Decramer, MD, PhD Universitaire Ziekenhuizen Leuven

Responsible Party: Marc Decramer, Prof. Dr., KU Leuven Identifier: NCT01293890     History of Changes
Other Study ID Numbers: B322201110500
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

Keywords provided by Marc Decramer, KU Leuven:
hospital admission

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases