PictureRx: An Intervention to Reduce Latino Health Disparities

June 11, 2012 updated by: M Brian Riley, PictureRx, LLC
The purpose of this randomized controlled trial is to evaluate the effect of Spanish-language illustrated medication instructions (PictureRx cards), compared to traditional medication instructions, on Latinos' understanding of their medication regimens. The study will also assess the effect on self-reported medication adherence. Patients with diabetes who attend participating clinics are eligible. The target sample size is 200.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

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
      • Nashville, Tennessee, United States, 37211
        • Saint Thomas Family Health Center - South

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:

  • Diabetes
  • Latino, Spanish speaker
  • Be at least 18 years old
  • Must be taking at least 1 chronic medication

Exclusion Criteria:

  • 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)
  • 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: Control
Usual care
Experimental: PictureRx cards
Illustrated format of medication instructions that includes pictures of pills and icons to show their purpose
Behavioral: PictureRx card
An illustrated format of medication instructions that includes pictures of the medications and icons to illustrate their purpose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Understanding of their Medication Regimen
Time Frame: Approximately 1 week after enrollment
The primary outcome will be patients' understanding of their medication regimen, as assessed by an interviewer-administered questionnaire.
Approximately 1 week after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported Adherence
Time Frame: Approximately 1 week after enrollment
As a secondary outcome, patients will report their self-reported adherence using a validated instrument.
Approximately 1 week after enrollment

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

March 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Estimate)

June 13, 2012

Last Update Submitted That Met QC Criteria

June 11, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R43MD004048 (U.S. NIH Grant/Contract)
  • 5R43MD004048-02 (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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