Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT00408733
Status:
COMPLETED
Last Update Posted:
2008-01-25
First Post:
2006-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating a Low-Literacy Discharge Medication Education Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-24', 'studyFirstSubmitDate': '2006-12-06', 'studyFirstSubmitQcDate': '2006-12-06', 'lastUpdatePostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Reported Medication Adherence', 'timeFrame': '2 & 4 weeks post discharge'}], 'secondaryOutcomes': [{'measure': 'Medication Knowledge, Patient Satisfaction & Self-Efficacy, Readmissions and Emergency Department Visits', 'timeFrame': '2weeks -8weeks post discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congestive Heart Failure', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '19896021', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient inclusion criteria will be:\n\n* 18 years of age or greater\n* Admission to the internal medical or cardiology services at LAC/USC Medical Center\n* Discharge directly from the medical service to home\n* During admission, being evaluated or treated for congestive heart failure or coronary artery disease.\n\nPatient Exclusion criteria :\n\n* Moderate or severe cognitive dysfunction\n* Severe psychiatric disability such that the patient has, or there is an application for, a conservator, or any psychiatric illness with current psychotic features\n* Not having speaking proficiency in either English or Spanish language.\n* If the patient was previously enrolled in the study on a prior hospitalization, he or she will also be excluded.\n\nNurse Inclusion Criteria:\n\n* Performing the patient education at hospital discharge for a patient enrolled in the study'}, 'identificationModule': {'nctId': 'NCT00408733', 'briefTitle': 'Evaluating a Low-Literacy Discharge Medication Education Tool', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Evaluating a Low-Literacy Discharge Medication Education Tool', 'orgStudyIdInfo': {'id': 'G06-09-104-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Intervention', 'interventionNames': ['Other: Medication Education Tool']}], 'interventions': [{'name': 'Medication Education Tool', 'type': 'OTHER', 'description': 'Picture and Icon-based Customizable Educational Tool', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles County/ USC Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Kristina M Cordasco, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kristina Cordasco', 'oldOrganization': 'UCLA'}}}}