Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use
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ClinicalTrials.gov Identifier: NCT01200849 |
Recruitment Status
:
Completed
First Posted
: September 14, 2010
Last Update Posted
: November 18, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Medication Understanding Diabetes Hypertension | Other: Enhanced Label | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 420 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Enhanced Label
Subjects in this arm will receive their prescriptions labeled with our enhanced, patient-friendly label.
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Other: Enhanced Label
A prescription drug label that has simplified text, more white space and overall is more patient-friendly.
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No Intervention: Standard Label
Subjects in this arm will receive their prescriptions labeled with a standard label.
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- Understanding of prescription medication [ Time Frame: Baseline, 3 month follow-up, 9 month follow-up ]Difference in understanding and comprehension of medication use as compared to control.
- Change in HbA1c or blood pressure readings [ Time Frame: Baseline, 3 month follow-up, 9 month follow-up ]

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Ages Eligible for Study: | 30 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200849
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Michael Wolf, Phd, MPH | Northwestern University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Michael S. Wolf, Professor, Northwestern University |
ClinicalTrials.gov Identifier: | NCT01200849 History of Changes |
Other Study ID Numbers: |
STU00005495 |
First Posted: | September 14, 2010 Key Record Dates |
Last Update Posted: | November 18, 2014 |
Last Verified: | November 2014 |