NCT01293890

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

3.5 years

First QC Date

February 10, 2011

Last Update Submit

July 29, 2013

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

adherencemedicationexacerbationshospital admission

Outcome Measures

Primary Outcomes (1)

  • time to exacerbation

    1 year

Secondary Outcomes (5)

  • exacerbation rate

    1 year

  • Forced expiratory volume in one second (FEV1)

    1 year

  • Number of hospitalization rate due to exacerbations

    1 year

  • Duration of hospitalizations due to exacerbations

    1 year

  • Functional status

    1 year

Study Arms (1)

COPD patients with hospital admission for exacerbation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven

Leuven, Flanders, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood urine

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Decramer, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Decramer, MD, PhD

CONTACT

3216346800marc.decramer@uz.kuleuven.be

Janssens Wim, MD, PhD

CONTACT

016/340 957wim.janssens@uz.kuleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2014

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

BE(1)