Medication Adherence Research in COPD Patients (MARC)

• ClinicalTrials.gov Identifier: NCT03174704
• Recruitment Status: Recruiting
• First Posted: June 2, 2017
• Last Update Posted: September 21, 2020
• Sponsor: Johns Hopkins University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

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.

Condition or disease
COPD; Medication Adherence

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 Design

• Study Type: Observational
• Estimated Enrollment: 360 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, 2022
• Estimated Study Completion Date: May 1, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Medication Adherence [ Time Frame: 5 years ]
   Measured by electronic medication monitoring

Secondary Outcome Measures :

1. % Predicted Forced Expiratory Volume (FEV) [ Time Frame: 5 years ]
   Measured by spirometry

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Criteria

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

Contacts and Locations

Locations

United States, Delaware

Christiana Care Health System; Recruiting

Newark, Delaware, United States, 19718

Contact: Tobi James, RN 302-733-4645 TobJames@ChristianaCare.org

Principal Investigator: Michael Vest, DO

United States, Maryland

Johns Hopkins University; Recruiting

Baltimore, Maryland, United States, 21224

Contact: Michelle N Eakin, Ph.D. 410-550-0487 meakin1@jhmi.edu

Contact: Research Team 410-550-1505

Sponsors and Collaborators

Johns Hopkins University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Michelle N Eakin, Ph.D.; Johns Hopkins University

More Information

• 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
• Last Update Posted: September 21, 2020
• Last Verified: September 2020

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