PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities

June 18, 2012 updated by: M Brian Riley, PictureRx, LLC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

470

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Chattanooga, Tennessee, United States, 37405
        • PictureRx, LLC (SAI Interactive)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Traditional prescription drug labels
Routine drug labels provided by the participating pharmacies
Experimental: Reformatted medication labels
Prescription drug container labels that follow a new format and also include illustrations
Behavioral: PictureRx medication label
Reformatted medication labels that adhere to current best practices for label design and also include illustrations

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy
Time Frame: Approximately 7 days
Patients' confidence in being able to follow their medication regimen.
Approximately 7 days
Self-reported adherence
Time Frame: Approximately 7 days
Patient self-reported adherence to the medications filled.
Approximately 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PictureRx, LLC

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: M Brian Riley, MA, PictureRx, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

June 19, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R43MD005805 (U.S. NIH Grant/Contract)
  • 1R43MD005805-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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