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NCT01998269 · ClinicalTrials.gov registry record
A Mixed Methods Approach to the Development and Testing of the Measure of Drug Self-Management (MeDS)
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 210
- Enrollment target
NCT01998269: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT01998269 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 210 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01998269 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 210 participants
- Enrollment target
Study 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
Primary Outcome
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 tha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-11 |
What the finished NCT01998269 record still lists
NCT01998269 is an observational study that tracks outcomes without assigning an intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01998269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01998269 about?
NCT01998269 is a clinical study titled "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 ...
What is the current status of trial NCT01998269?
This trial is currently completed. The enrollment target is 210 participants. The study started on 2013-11. Estimated completion is 2014-11.
Who is sponsoring clinical trial NCT01998269?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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