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Medication Adherence Research in COPD Patients (MARC)

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ClinicalTrials.gov Identifier: NCT03174704
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

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.


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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



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



Information from the National Library of Medicine

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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
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
  • 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


Information from the National Library of Medicine

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


Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Michelle N Eakin, Ph.D.    410-550-0487    meakin1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Michelle N Eakin, Ph.D. Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03174704     History of Changes
Other Study ID Numbers: IRB00091482
1R01HL128620-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No