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

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.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ambulatory Care Center

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Measure of Medication Self-Management (MeDS)

Time frame: cross-sectional, 1 hour interview after clinic visit

The MeDS is an assessment of medication self-management skills. The MeDS tool has 14 questions, the minimum score is 0 (poor medication self-management skills) and the maximum score is 14 (adequate self-management skills). The internal consistency of the scale is .72 (cronbach's alpha), which is considered adequate internal consistency. The MeDS was compared to The Morisky Medication Adherence Scale is one of the most commonly used assessments of medication adherence. It includes 8 questions that assess various factors that can affect medication use, such as forgetfulness, busyness and side effects. Scores range from 0 to 8, with lower scores reflecting better adherence.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

Merck Sharp & Dohme LLC
Northwestern University

Registry information

Official study title

A Mixed Methods Approach to the Development and Testing of the Measure of Drug Self-Management (MeDS), an Assessment for Use in Clinical Settings Among English and Spanish-speaking Patients With Hypertension and Diabetes.

Acronym: MeDS

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Nov 28, 2013
Registry last updated: Apr 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed