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

• ClinicalTrials.gov Identifier: NCT01998269
• Recruitment Status: Completed
• First Posted: November 28, 2013
• Results First Posted: April 2, 2015
• Last Update Posted: April 2, 2015
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Merck Sharp & Dohme Corp.; Northwestern University
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

Brief Summary:

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.

Condition or disease
Diabetes; Hypertension

Study Design

• Study Type: Observational
• Actual Enrollment: 210 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official 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.
• Study Start Date: November 2013
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 2014

Groups and Cohorts

Group/Cohort
Adult patients with diabetes and hypertension

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Adult, primary care patients with diabetes and hypertension

Criteria

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.

Contacts and Locations

Locations

United States, North Carolina

Ambulatory Care Center

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Merck Sharp & Dohme Corp.

Northwestern University

Investigators

• Principal Investigator: Stacy C Bailey, PhD MPH; University of North Carolina, Chapel Hill

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT01998269
• Other Study ID Numbers: 13-3049
• First Posted: November 28, 2013
• Results First Posted: April 2, 2015
• Last Update Posted: April 2, 2015
• Last Verified: November 2014

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases