COPDMARCNCT03174704
Medication Adherence Research in COPD Patients
An observational study of COPD and Medication Adherence, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Medication Adherence
- How many people
- 314 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2017to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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:
- 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
Who cannot join
- Non-English speaking
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21224
Christiana Care Health System
Newark, Delaware, 19718
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD, Medication Adherence
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Medication Adherence
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Measured by electronic medication monitoring
Measured: 5 years
Secondary outcomes (1)
% Predicted Forced Expiratory Volume (FEV)
Measured by spirometry
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start1 May 2017
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michelle N Eakin, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174704
- Sponsor's protocol ID
- IRB00091482
- Other IDs
- 1R01HL128620-01A1
- Acronym
- MARC
- Status last verified
- May 2023
- First submitted
- 31 May 2017
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Determinants of Medication Adherence in COPD
- ClinicalTrials.gov ID
- NCT03174704
- Acronym / sponsor ID
- MARC / IRB00091482
- Conditions
- COPD, Medication Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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:
- Cognitive ability to provide informed consent
Key exclusion criteria (1 listed)
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medication Adherence
Time frame: 5 years
Measured by electronic medication monitoring
1 secondary outcome
% Predicted Forced Expiratory Volume (FEV)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No. We do not share individual participant data.
Related trials for COPD
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruiting
High-Intensity Interval Alternating Concentric-Eccentric Training in Chronic Respiratory Disease
Chronic Respiratory Disease, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Recruiting
Combinaison of Virtual Reality and Rehabilitation to Improve Muscle Function, Exercise Tolerance, Exertional Symptoms and Dyspnea in Patients With Chronic Respiratory Disease: a Randomized Cross-over Trial
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Nurse-Led Pulmonary Rehabilitation on Dyspnea, Fatigue and Self-Efficacy in COPD Patients
Chronic Obstructive Pulmonary Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle N Eakin, Ph.D. principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Medication Adherence, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.