PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities

NCT ID: NCT01622686

Last Updated: 2012-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Health Behavior Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Traditional prescription drug labels

Routine drug labels provided by the participating pharmacies

Group Type NO_INTERVENTION

No interventions assigned to this group

Reformatted medication labels

Prescription drug container labels that follow a new format and also include illustrations

Group Type EXPERIMENTAL

PictureRx medication label

Intervention Type BEHAVIORAL

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

Interventions

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PictureRx medication label

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

PictureRx, LLC

OTHER

Sponsor Role lead

Responsible Party

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M Brian Riley

Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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M Brian Riley, MA

Role: PRINCIPAL_INVESTIGATOR

PictureRx, LLC

Locations

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PictureRx, LLC (SAI Interactive)

Chattanooga, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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1R43MD005805-01

Identifier Type: NIH

Identifier Source: secondary_id

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1R43MD005805

Identifier Type: NIH

Identifier Source: org_study_id

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