PictureRx: An Intervention to Reduce Latino Health Disparities

Diabetes Clinical Trial

Official title:

PictureRx: An Intervention to Reduce Latino Health Disparities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618409
• Other study ID #: 1R43MD004048
• Secondary ID: 5R43MD004048-02
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: June 11, 2012
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: PictureRx, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes
• Medication Adherence

Intervention

Behavioral:
• PictureRx card
An illustrated format of medication instructions that includes pictures of the medications and icons to illustrate their purpose

Locations

Country	Name	City	State
United States	Saint Thomas Family Health Center - South	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
PictureRx, LLC	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Understanding of their Medication Regimen	The primary outcome will be patients' understanding of their medication regimen, as assessed by an interviewer-administered questionnaire.	Approximately 1 week after enrollment	No
Secondary	Self-reported Adherence	As a secondary outcome, patients will report their self-reported adherence using a validated instrument.	Approximately 1 week after enrollment	No