PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01622686

Enrollment

470

Registered

2012-06-19

Start date

2011-11-30

Completion date

2012-05-31

Last updated

2012-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior, Medication Adherence

Keywords

Prescription Labels, Low Health Literacy, Limited English Proficiency, Spanish

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.

Interventions

BEHAVIORALPictureRx medication label

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Patient understanding of their medication regimen.	Approximately 7 days	Patient understanding of the instructions for taking their medications correctly.

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026