Medication Adherence Research in COPD Patients (MARC)
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ClinicalTrials.gov Identifier: NCT03174704 |
Recruitment Status :
Active, not recruiting
First Posted : June 2, 2017
Last Update Posted : May 6, 2022
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Condition or disease |
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COPD Medication Adherence |
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.
Study Type : | Observational |
Actual Enrollment : | 314 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Longitudinal Determinants of Medication Adherence in COPD |
Actual Study Start Date : | May 1, 2017 |
Estimated Primary Completion Date : | May 1, 2023 |
Estimated Study Completion Date : | May 1, 2023 |
- Medication Adherence [ Time Frame: 5 years ]Measured by electronic medication monitoring
- % Predicted Forced Expiratory Volume (FEV) [ Time Frame: 5 years ]Measured by spirometry

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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: | Probability Sample |
Inclusion Criteria:
- 40 years of age or older
- Physician diagnosis of COPD
- Prescribed a long-term controller medication for COPD
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Moderate COPD on the basis of meeting one of the following criteria:
- Gold Stage II-IV disease with forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ≤70% and FEV1 (% predicted) <80% or
- One or more hospital admissions, two or more emergency department (ED) visits, or prescription of oral steroids for COPD exacerbation in the past 12 months or ever having used home oxygen
- Cognitive ability to provide informed consent
Exclusion Criteria:
- Non-English speaking

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 ClinicalTrials.gov identifier (NCT number): NCT03174704
United States, Delaware | |
Christiana Care Health System | |
Newark, Delaware, United States, 19718 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Michelle N Eakin, Ph.D. | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT03174704 |
Other Study ID Numbers: |
IRB00091482 1R01HL128620-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | June 2, 2017 Key Record Dates |
Last Update Posted: | May 6, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | We do not share individual participant data. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |