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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Northwestern University | OTHER |
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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:
H1: The MeDS will strongly correlate with other self-report adherence measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with diabetes and hypertension |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult, primary care patients with diabetes and hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Stacy C Bailey, PhD MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatory Care Center | Chapel Hill | North Carolina | 27599 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Patients With Diabetes and Hypertension | English-speaking, adult patients with diabetes and hypertension. There are no study arms - this was a cross-sectional study to develop and validate a measure of medication self-management skills. A total of 210 patients were recruited. 17 participated in focus groups to help develop the tool. The other 193 participated in item performance testing. The results of item performance testing are reported here. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Patients With Diabetes and Hypertension | There are no study arms. This was a cross-sectional study to develop a scale. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | cross-sectional, 1 hour interview after clinic visit |
|
There is no adverse event reporting. This was a cross sectional study to develop a medication self-management scale.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adult Patients With Diabetes and Hypertension | There are no study arms. This was a cross-sectional study to develop a medication self-management scale. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stacy Bailey | University of North Carolina at Chapel Hill | 919-843-9834 | scbailey@unc.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 0 |
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| 0 |
| 0 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |