PictureRx: An Intervention to Reduce Latino Health Disparities

This study has been completed.
Sponsor:
Collaborator:
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 September 14, 2014