View Clinical Trial (Medical Research Study)
Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60611 |
| Conditions: |
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Medication Understanding - Diabetes - Hypertension |
| Purpose: |
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The overall objective of this study is to test the efficacy of an evidence-based, enhanced
Rx container label design to improve Spanish speaking patients' understanding of
instructions for use.
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| Study Summary: |
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The investigators will conduct a randomized controlled trial (N=960) to evaluate the
efficacy of the enhanced Rx container label to improve, Spanish speaking, diabetic and/or
hypertensive patients' understanding of actual prescribed medicines, compared to a standard
label format. Spanish-speaking patients with type II diabetes and/or hypertension at
safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts Central - NSC)
receive all their prescribed medicines from this location. Recruited diabetic and/or
hypertensive subjects in this study will be randomly assigned to either intervention
(enhanced Rx container label) or control (standard Rx label). All pill-form, regular dosing
schedule medicines, including diabetes and hypertensive (i.e. ACE inhibitor) medicines
associated with patients' treatment will be labeled according to study arm by the
central-fill pharmacy. Study subjects will be interviewed at the time of dispensing the
prescribed medicines at the clinic, again three months later (dispensing of refill), and
finally nine months after baseline (dispensing of refill). Pharmacy refill data and medical
record information - linked at these clinics - will be collected for exploratory analyses.
Patients' ability to read and demonstrate Rx label instructions, including auxiliary
warnings, will be the primary outcomes for this aim. Data from the actual use trial will be
processed, reviewed, analyzed (in order of hypotheses), and reports prepared during the
final months of this last phase of the study. We anticipate several manuscripts to be
developed as a result of this project, supported by the diverse key personnel and
collaborating faculty enlisted.
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| Criteria: |
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Inclusion Criteria:
- Diagnosis of Type II diabetes or hypertension in their medical chart
- Spanish speaking
- 30 years or older
Exclusion Criteria:
- Uncorrectable hearing or visual impairment.
- Too ill to participate
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| NCT ID: |
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NCT01200849 |
| Primary Contact: |
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Principal Investigator
Michael Wolf, Phd, MPH
Northwestern University
Kathryn I Davis, MPH
Phone: 312-503-3292
Email: kathryn-davis@northwestern.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chicago, Illinois 60611
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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