PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities

Health Behavior Clinical Trial

Official title:

PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622686
• Other study ID #: 1R43MD005805
• Secondary ID: 1R43MD005805-01
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: June 18, 2012
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: PictureRx, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Health Behavior
• Medication Adherence

Intervention

Behavioral:
• PictureRx medication label
Reformatted medication labels that adhere to current best practices for label design and also include illustrations

Locations

Country	Name	City	State
United States	PictureRx, LLC (SAI Interactive)	Chattanooga	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
PictureRx, LLC	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient understanding of their medication regimen.	Patient understanding of the instructions for taking their medications correctly.	Approximately 7 days	No
Secondary	Self-efficacy	Patients' confidence in being able to follow their medication regimen.	Approximately 7 days	No
Secondary	Self-reported adherence	Patient self-reported adherence to the medications filled.	Approximately 7 days	No