PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities
2 other identifiers
interventional
470
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 11, 2012
CompletedFirst Posted
Study publicly available on registry
June 19, 2012
CompletedJune 19, 2012
June 1, 2012
6 months
June 11, 2012
June 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient understanding of their medication regimen.
Patient understanding of the instructions for taking their medications correctly.
Approximately 7 days
Secondary Outcomes (2)
Self-efficacy
Approximately 7 days
Self-reported adherence
Approximately 7 days
Study Arms (2)
Traditional prescription drug labels
NO INTERVENTIONRoutine drug labels provided by the participating pharmacies
Reformatted medication labels
EXPERIMENTALPrescription drug container labels that follow a new format and also include illustrations
Interventions
Reformatted medication labels that adhere to current best practices for label design and also include illustrations
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PictureRx, LLC (SAI Interactive)
Chattanooga, Tennessee, 37405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M Brian Riley, MA
PictureRx, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Research
Study Record Dates
First Submitted
June 11, 2012
First Posted
June 19, 2012
Study Start
November 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
June 19, 2012
Record last verified: 2012-06