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

NCT ID: NCT01998269

Last Updated: 2015-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-11-30

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.

Conditions

Diabetes; Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Adult patients with diabetes and hypertension

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacy C Bailey, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Ambulatory Care Center

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

13-3049

Identifier Type: -

Identifier Source: org_study_id