Medication Adherence Research in COPD Patients (MARC)

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence; COPD

Detailed Description

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
• Enrollment (Actual): 314

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health System
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study will enroll 360 patients (40 years of age or older) with physician diagnosed COPD and are prescribed a long-term controller medication for COPD

Description

Inclusion Criteria:

• 40 years of age or older
• Physician diagnosis of COPD
• Prescribed a long-term controller medication for COPD

• Moderate COPD on the basis of meeting one of the following criteria:

  1. Gold Stage II-IV disease with forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ≤70% and FEV1 (% predicted) <80% or
  2. 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	Measured by electronic medication monitoring	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Predicted Forced Expiratory Volume (FEV)	Measured by spirometry	5 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Michelle N Eakin, Ph.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB00091482; 1R01HL128620-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No