Diabetes, Hypertension
Conditions
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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Northwestern University
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Medication Self-Management (MeDS) | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 210 patients were recruited from the University of North Carolina Ambulatory Care Center. 17 patients participated in focus groups to help develop the medication self-management tool (MeDS tool). The other 193 participated in item performance testing. The results of item performance testing are reported here.
Participants by arm
| Arm | Count |
|---|---|
| Adult Patients With Diabetes and Hypertension There are no study arms. This was a cross-sectional study to develop a scale. | 193 |
| Total | 193 |
Baseline characteristics
| Characteristic | Adult Patients With Diabetes and Hypertension |
|---|---|
| Age, Continuous | 61.1 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 105 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 83 Participants |
| Sex: Female, Male Female | 116 Participants |
| Sex: Female, Male Male | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: cross-sectional, 1 hour interview after clinic visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Patients With Diabetes and Hypertension | Measure of Medication Self-Management (MeDS) | MeDS tool | 10.9 units on a scale | Standard Deviation 2.6 |
| Adult Patients With Diabetes and Hypertension | Measure of Medication Self-Management (MeDS) | Morisky Adherence Measure | 2.5 units on a scale | Standard Deviation 1.7 |
Comparison: We examined correlations between patient scores on the Measure of Medication Self-Management (MeDS) and the 8-item Morisky Medication Adherence questionnaire.p-value: <0.001Correlation