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

Hypertension Clinical Trial

— MeDS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998269
• Other study ID #: 13-3049
• Status: Completed
• Phase: N/A
• First received: November 15, 2013
• Last updated: April 1, 2015
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes
• Hypertension

Locations

Country	Name	City	State
United States	Ambulatory Care Center	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Merck Sharp & Dohme Corp., Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Medication Self-Management (MeDS)	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.	cross-sectional, 1 hour interview after clinic visit	No