PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities

Not Applicable

Completed

• Conditions: Health Behavior; Medication Adherence

• Registration Number: NCT01622686
• Lead Sponsor: PictureRx, LLC

Brief Summary

This randomized controlled trial seeks to test the effect of reformatted prescription drug container labels, compared to usual labels, on participants' understanding of their medications. The study will also assess the effect on self-efficacy and self-reported medication adherence. English and Spanish speaking patients are eligible, with a planned sample size of up to 500 adults.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-06
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-18
• Last Update Submitted: 2012-06-18
• Study First Posted: 2012-06-19
• Last Update Posted: 2012-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

• Be at least 18 years old,
• Fluency in English or Spanish
• Manage their own prescription medicines, and
• Have recently filled at least 1 new prescription medication (e.g, a medicine or medication dose that they have not taken before) and have their new prescription bottle information with them.

Exclusion Criteria

• Excludes health professionals (such as a doctor, nurse or pharmacist)
• Too ill to participate in an interview
• Do not have a telephone
• Having visual acuity worse than 20/50 via Rosenbaum Visual Acuity exam (eyechart)
• Persons picking up new medicines for others
• Inability to communicate in either Spanish or English
• Overt psychiatric illnesses, overt delirium or dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient understanding of their medication regimen.	Approximately 7 days	Patient understanding of the instructions for taking their medications correctly.

Secondary Outcome Measures

Name	Time	Method
Self-reported adherence	Approximately 7 days	Patient self-reported adherence to the medications filled.
Self-efficacy	Approximately 7 days	Patients' confidence in being able to follow their medication regimen.

Trial Locations

Locations (1)

PictureRx, LLC (SAI Interactive); 🇺🇸 Chattanooga, Tennessee, United States