Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use

Hypertension Clinical Trial

Official title:

Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200849
• Other study ID #: STU00005495
• Status: Completed
• Phase: N/A
• First received: September 2, 2010
• Last updated: November 17, 2014
• Start date: October 2010
• Est. completion date: January 2014

Study information

• Verified date: November 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Medication Understanding

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understanding of prescription medication	Difference in understanding and comprehension of medication use as compared to control.	Baseline, 3 month follow-up, 9 month follow-up	No
Secondary	Change in HbA1c or blood pressure readings		Baseline, 3 month follow-up, 9 month follow-up	No