Clinical trial NCT01998269: A Mixed Methods Approach to the Development and Testing of the Measure of Drug Self-Management (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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Hypertension
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Northwestern University
First posted: 2013-11-28
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, primary care patients with diabetes and hypertension

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.


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.

Primary outcomes:
measure: Measure of Medication Self-Management (MeDS)
timeFrame: cross-sectional, 1 hour interview after clinic visit
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Ambulatory Care Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Stacy C Bailey, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: