A Mixed Methods Approach to the Development and Testing of the Measure of Drug Self-Management (MeDS)

Completed

Conditions studied: Diabetes, Hypertension

In brief

The study objective is to develop and test a Measure of Drug Self-Management for use in clinical settings among patients with hypertension and diabetes. While medication non-adherence is a highly recognized public health and patient safety concern, it is rarely assessed in a routine and consistent manner in clinical settings. With the aging of the US population and rising rates of chronic disease, an increasing number of adults are being prescribed multi-drug regimens that require greater self-management skills. Despite the complexity of medication use, adherence has most commonly been measured as a limited set of behaviors (i.e., filling a prescription, taking doses). This emphasis has, over time, simplified how we think of prescription (Rx) medication use and directed attention away from the full range of tasks associated with effective Rx self-management. The field of health literacy research has deconstructed these tasks in considerable detail in recent years, and can offer insight into a more comprehensive measurement of patients' outpatient Rx use. There is a clear need for a brief, yet inclusive, measure of adherence that can be used in clinical settings to routinely assess patients' use of complex Rx regimens. Such an assessment could be used to guide clinicians in addressing specific patient challenges to safe and appropriate medication use. In response to this need, our study proposes to develop a new assessment of medication self-management. This unique measure will utilize health literacy best practices to promote patient comprehension and ease-of-use; it will also be tailored to patients' actual regimens via electronic health record (EHR) data. Finally, the tool will be available in both English and Spanish to support use among diverse patient populations. Our study aims are to: 1. Develop and refine a Measure of Drug Self-Management (MeDS) prototype. 2. Inform the content, structure and delivery of the MeDS through targeted discussions with patients, providers and information technology specialists. 3. Test the reliability and validity of the MeDS among patients with diabetes and hypertension H1: The MeDS will strongly correlate with other self-report adherence measures.

Key facts

Study ID

NCT01998269

Run by

University of North Carolina, Chapel Hill

People needed

210

Starts

2013-11-01

Expected to finish

2014-11-01

Last updated by the study team

2015-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• be ≥ 18 years old,
• have a diagnosis of diabetes and hypertension,
• be prescribed 3 or more drugs to treat these conditions,
• speak English or Spanish as their primary language,
• have primary responsibility for administering their own medications,
• be a registered UNC patient.

You may not qualify if…

• severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation.

Where it is running

• Ambulatory Care Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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