Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use

Not Applicable

Completed

• Conditions: Medication Understanding; Diabetes; Hypertension
• Interventions: Other: Enhanced Label

• Registration Number: NCT01200849
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Study Start: 2010-10
• Primary Completion: 2013-01
• Study Completion: 2014-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• Diagnosis of Type II diabetes or hypertension in their medical chart
• Spanish speaking
• 30 years or older

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Exclusion Criteria

• Uncorrectable hearing or visual impairment.
• Too ill to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Label	Enhanced Label	Subjects in this arm will receive their prescriptions labeled with our enhanced, patient-friendly label.

Primary Outcome Measures

Name	Time	Method
Understanding of prescription medication	Baseline, 3 month follow-up, 9 month follow-up	Difference in understanding and comprehension of medication use as compared to control.

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c or blood pressure readings	Baseline, 3 month follow-up, 9 month follow-up

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States