Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01200849
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : November 18, 2014
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Michael S. Wolf, Northwestern University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Medication Understanding Diabetes Hypertension Other: Enhanced Label Not Applicable

Detailed Description:
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.

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.
Other: Enhanced Label
A prescription drug label that has simplified text, more white space and overall is more patient-friendly.

No Intervention: Standard Label
Subjects in this arm will receive their prescriptions labeled with a standard label.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Change in HbA1c or blood pressure readings [ Time Frame: Baseline, 3 month follow-up, 9 month follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01200849

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Michael Wolf, Phd, MPH Northwestern University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael S. Wolf, Professor, Northwestern University 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