NCT01618409

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

9 months

First QC Date

June 11, 2012

Last Update Submit

June 11, 2012

Conditions

Keywords

PictureRxHealth LiteracyLimited English ProficiencyLatinosSpanish

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Self-reported Adherence

    Approximately 1 week after enrollment

Study Arms (2)

PictureRx cards

EXPERIMENTAL

Illustrated format of medication instructions that includes pictures of pills and icons to show their purpose

Behavioral: PictureRx card

Control

NO INTERVENTION

Usual care

Interventions

PictureRx cardBEHAVIORAL

An illustrated format of medication instructions that includes pictures of the medications and icons to illustrate their purpose

PictureRx cards

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes
  • Latino, Spanish speaker
  • Be at least 18 years old
  • Must be taking at least 1 chronic medication

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas Family Health Center - South

Nashville, Tennessee, 37211, United States

Location

MeSH Terms

Conditions

Medication AdherenceDiabetes Mellitus

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • M Brian Riley, MA

    PictureRx, LLC

    PRINCIPAL INVESTIGATOR

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 13, 2012

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations