CClinicalTrials.gg
CompletedNCT00408733Updated Jan 25, 2008

Evaluating a Low-Literacy Discharge Medication Education Tool

An interventional study of Medication Education Tool in Congestive Heart Failure and Coronary Artery Disease, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-25.

Sponsored by University of California, Los Angeles · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
287
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Recent studies have demonstrated that patients sub-optimally understand hospital discharge medication instructions Health literacy has been shown to be an important factor in patient understanding of medical information , and following medication instructions.

The primary aim of this project is to test the efficacy of a low-literacy discharge medication education tool on medication adherence, and patient knowledge and understanding of inpatient discharge medications, in a low-income population with low health literacy levels. This evaluation is a prospective trial with patients randomly assigned to either receiving this tool or receiving the current standard of care. Given the complexity of the discharge medication regimen for the conditions of congestive heart failure (CHF) and coronary artery disease (CAD), and the proven effectiveness of these medications in the post discharge period, this trial will focus on the subpopulation of patients hospitalized with these two conditions.

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Conditions studied

  • Congestive Heart Failure
  • Coronary Artery Disease
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 287 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

Patient inclusion criteria will be:

  • 18 years of age or greater
  • Admission to the internal medical or cardiology services at LAC/USC Medical Center
  • Discharge directly from the medical service to home
  • During admission, being evaluated or treated for congestive heart failure or coronary artery disease.

Patient Exclusion criteria :

  • Moderate or severe cognitive dysfunction
  • Severe psychiatric disability such that the patient has, or there is an application for, a conservator, or any psychiatric illness with current psychotic features
  • Not having speaking proficiency in either English or Spanish language.
  • If the patient was previously enrolled in the study on a prior hospitalization, he or she will also be excluded.

Nurse Inclusion Criteria:

  • Performing the patient education at hospital discharge for a patient enrolled in the study
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
287 participants (actual)

Study arms

  • No intervention
    1
  • Experimental
    2

    Intervention

    Other: Medication Education Tool

Interventions

  • OtherMedication Education Tool

    Picture and Icon-based Customizable Educational Tool

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What researchers measure

Primary outcomes

  1. Self-Reported Medication Adherence

    Time frame: 2 & 4 weeks post discharge

Secondary outcomes

  1. Medication Knowledge, Patient Satisfaction & Self-Efficacy, Readmissions and Emergency Department Visits

    Time frame: 2weeks -8weeks post discharge

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Study locations

1 site
  • Los Angeles County/ USC Medical Center
    Los Angeles, California, United States
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References and documents

Publications

  • Cordasco KM, Asch SM, Bell DS, Guterman JJ, Gross-Schulman S, Ramer L, Elkayam U, Franco I, Leatherwood CL, Mangione CM. A low-literacy medication education tool for safety-net hospital patients. Am J Prev Med. 2009 Dec;37(6 Suppl 1):S209-16. doi: 10.1016/j.amepre.2009.08.018. PubMed 19896021 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00408733
Lead sponsor
University of California, Los Angeles
First posted
Dec 7, 2006
Start date
Jan 2007
Primary completion
Jul 2007
Completion
Aug 2007
Last update
Jan 25, 2008

Study contacts

Kristina M Cordasco, MD, MPH
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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