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OpenTrials
Completed

NCT Number: NCT01622686

PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities

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.

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Key information

Conditions

Health Behavior Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PictureRx, LLC (SAI Interactive)

Chattanooga, Tennessee, 37405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PictureRx medication label

Behavioral

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

Primary outcomes

  1. Patient understanding of their medication regimen.

    Time frame: Approximately 7 days

    Patient understanding of the instructions for taking their medications correctly.

Secondary outcomes

  1. Self-efficacy

    Time frame: Approximately 7 days

    Patients' confidence in being able to follow their medication regimen.

  2. Self-reported adherence

    Time frame: Approximately 7 days

    Patient self-reported adherence to the medications filled.

Sponsors and collaborators

Lead sponsor

PictureRx, LLC

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 19, 2012
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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