Medication Adherence Research in COPD Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 3/7/2019 |
| Start Date: | May 1, 2017 |
| End Date: | May 1, 2022 |
Longitudinal Determinants of Medication Adherence in COPD
Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death, affects
over 24 million people in the US and is the leading cause of disability with projected
healthcare costs at almost $50 billion. The goal of this study is to identify novel and
potentially powerful targets for behavioral interventions in COPD which has been understudied
despite its tremendous detrimental impact on overall public health.
over 24 million people in the US and is the leading cause of disability with projected
healthcare costs at almost $50 billion. The goal of this study is to identify novel and
potentially powerful targets for behavioral interventions in COPD which has been understudied
despite its tremendous detrimental impact on overall public health.
The Centers for Medicare and Medicaid Services (CMS) has specifically targeted COPD hospital
readmissions as a meaningful quality outcome that could result in financial penalties
highlighting the significant impact of COPD on our overall health system. The growing
availability of efficacious medication, stands in stark contrast to the poor health outcomes
experienced by COPD patients. One possible explanation for this gap is low rates of
medication adherence; some studies report that only 25% of COPD patients take at least 80% of
their prescribed medications. Pharmacy refill records indicate that adherence to COPD
medications is significantly lower than adherence rates seen in other chronic illnesses
including hypertension, diabetes, and congestive heart failure. Significant negative long
term health outcomes may be magnified by non-adherence to prescribed medications in COPD.
This study proposes to systematically identify modifiable determinants of adherence in COPD
based on the Theory of Self-Regulation in 360 patients with COPD. A novel and significant
innovation of this study is the use of mobile health (mhealth) technology to objectively
assess medication use. No previous study of self-regulation theory has utilized objective
measure of adherence. A further innovation of the study is the use of ecological momentary
assessment (EMA) of patient reported symptoms and beliefs to evaluate longitudinal
associations between observation (patient symptoms) judgements (medication use to relieve
symptoms), and reactions (self-efficacy, outcome expectancy, and medication beliefs) in real
time. This study will be the first to objectively evaluate the application of the
Self-Regulation Theory in COPD and to examine the long-term longitudinal impact of medication
adherence on disease progression in a diverse sample.
readmissions as a meaningful quality outcome that could result in financial penalties
highlighting the significant impact of COPD on our overall health system. The growing
availability of efficacious medication, stands in stark contrast to the poor health outcomes
experienced by COPD patients. One possible explanation for this gap is low rates of
medication adherence; some studies report that only 25% of COPD patients take at least 80% of
their prescribed medications. Pharmacy refill records indicate that adherence to COPD
medications is significantly lower than adherence rates seen in other chronic illnesses
including hypertension, diabetes, and congestive heart failure. Significant negative long
term health outcomes may be magnified by non-adherence to prescribed medications in COPD.
This study proposes to systematically identify modifiable determinants of adherence in COPD
based on the Theory of Self-Regulation in 360 patients with COPD. A novel and significant
innovation of this study is the use of mobile health (mhealth) technology to objectively
assess medication use. No previous study of self-regulation theory has utilized objective
measure of adherence. A further innovation of the study is the use of ecological momentary
assessment (EMA) of patient reported symptoms and beliefs to evaluate longitudinal
associations between observation (patient symptoms) judgements (medication use to relieve
symptoms), and reactions (self-efficacy, outcome expectancy, and medication beliefs) in real
time. This study will be the first to objectively evaluate the application of the
Self-Regulation Theory in COPD and to examine the long-term longitudinal impact of medication
adherence on disease progression in a diverse sample.
Inclusion Criteria:
- 40 years of age or older
- Physician diagnosis of COPD
- Gold Stage II-IV disease with forced expiratory volume in 1 second (FEV1)/forced vital
capacity (FVC) ≤70% and FEV1 (% predicted) <80%
- Prescribed a long-term controller medication for COPD
- Cognitive ability to provide informed consent
Exclusion Criteria:
- Non-English speaking
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Phone: 410-550-0487
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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