NCT01618461

Brief Summary

Research shows that well-developed icons and other pictorials aid in the comprehension of medication information and are effective in improving patients' medication management. This experimental study seeks to test the effect of icons and structured medication information on subjects' processing and recall of simulated medication instructions in a computer testing environment. The study planned to enroll 200 subjects.

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 Jun 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
12 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

1 month

First QC Date

June 11, 2012

Last Update Submit

June 11, 2012

Conditions

Keywords

Prescription drug informationMedication management

Outcome Measures

Primary Outcomes (1)

  • Understanding of medication instructions

    Participants' ability to state the drug indication

    Within 10-20 minutes

Secondary Outcomes (1)

  • Recall of medication instructions

    Within 10-20 minutes

Study Arms (4)

Text instructions

NO INTERVENTION

Medication instructions displayed in text format

Drug indication icons

EXPERIMENTAL

Icons illustrate the purpose of each medication

Behavioral: Drug indication icons

Structured instructions

EXPERIMENTAL

Graphical format shows what time(s) of day each medication should be taken

Behavioral: Structured instructions

Icons + Structured instructions

EXPERIMENTAL

Icons illustrate the purpose of each medication, and a graphical format shows what time(s) of day each medication should be taken

Behavioral: Drug indication iconsBehavioral: Structured instructions

Interventions

Icons illustrate the purpose of each medication

Drug indication iconsIcons + Structured instructions

Graphical format shows what time(s) of day each medication should be taken

Icons + Structured instructionsStructured instructions

Eligibility Criteria

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

You may qualify if:

  • Be at least 18 years old
  • Fluency in English or Spanish
  • Manage their own prescription medicines, and
  • Be taking at least one chronic medication

You may not qualify if:

  • Too ill to complete the experiment
  • 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 (2)

Saint Thomas Family Health Center - West

Nashville, Tennessee, 37209, United States

Location

Saint Thomas Family Health Center - South

Nashville, Tennessee, 37211, United States

Location

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
FACTORIAL
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

June 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations