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PictureRx: An Intervention to Reduce Latino Health Disparities

This study has been completed.
Sponsor:
Collaborator:
National Center on Minority Health and Health Disparities (NCMHD)
Information provided by (Responsible Party):
M Brian Riley, PictureRx, LLC
ClinicalTrials.gov Identifier:
NCT01618409
First received: June 11, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Medication Adherence
Diabetes
 Behavioral: PictureRx card

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: PictureRx: An Intervention to Reduce Latino Health Disparities

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by PictureRx, LLC:

Primary Outcome Measures:
  • Patient Understanding of their Medication Regimen [ Time Frame: Approximately 1 week after enrollment ] [ Designated as safety issue: No ]
    The primary outcome will be patients' understanding of their medication regimen, as assessed by an interviewer-administered questionnaire.


Secondary Outcome Measures:
  • Self-reported Adherence [ Time Frame: Approximately 1 week after enrollment ] [ Designated as safety issue: No ]
    As a secondary outcome, patients will report their self-reported adherence using a validated instrument.


Enrollment: 200
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: Control
Usual care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618409

Locations
United States, Tennessee
Saint Thomas Family Health Center - South
Nashville, Tennessee, United States, 37211
Sponsors and Collaborators
PictureRx, LLC
National Center on Minority Health and Health Disparities (NCMHD)
Investigators
Principal Investigator: M Brian Riley, MA PictureRx, LLC
  More Information

No publications provided

Responsible Party: M Brian Riley, Director of Research, PictureRx, LLC
ClinicalTrials.gov Identifier: NCT01618409     History of Changes
Other Study ID Numbers: 1R43MD004048, 5R43MD004048-02
Study First Received: June 11, 2012
Last Updated: June 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by PictureRx, LLC:
PictureRx
Health Literacy
Limited English Proficiency
Latinos
Spanish

ClinicalTrials.gov processed this record on May 22, 2013