Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-30 @ 3:00 PM
Study NCT ID:
NCT01618461
Status:
COMPLETED
Last Update Posted:
2012-06-13
First Post:
2012-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PictureRx: An Intervention to Reduce Latino Health Disparities (Supplement: Medical Icons)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-11', 'studyFirstSubmitDate': '2012-06-11', 'studyFirstSubmitQcDate': '2012-06-11', 'lastUpdatePostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Understanding of medication instructions', 'timeFrame': 'Within 10-20 minutes', 'description': "Participants' ability to state the drug indication"}], 'secondaryOutcomes': [{'measure': 'Recall of medication instructions', 'timeFrame': 'Within 10-20 minutes', 'description': "Participants' ability to recall the instructions after viewing a series of medications"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prescription drug information', 'Medication management'], 'conditions': ['Understanding of Medication Instructions', 'Recall of Medication Instructions']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be at least 18 years old\n* Fluency in English or Spanish\n* Manage their own prescription medicines, and\n* Be taking at least one chronic medication\n\nExclusion Criteria:\n\n* Too ill to complete the experiment\n* Having visual acuity worse than 20/50 via Rosenbaum Visual Acuity exam (eyechart)\n* Inability to communicate in either Spanish or English\n* Overt psychiatric illnesses, overt delirium or dementia'}, 'identificationModule': {'nctId': 'NCT01618461', 'briefTitle': 'PictureRx: An Intervention to Reduce Latino Health Disparities (Supplement: Medical Icons)', 'organization': {'class': 'OTHER', 'fullName': 'PictureRx, LLC'}, 'officialTitle': 'PictureRx: An Intervention to Reduce Latino Health Disparities (Supplement: Medical Icons)', 'orgStudyIdInfo': {'id': '3R43MD004048-02S1', 'link': 'https://reporter.nih.gov/quickSearch/3R43MD004048-02S1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '3R43MD004048-02S1', 'link': 'https://reporter.nih.gov/quickSearch/3R43MD004048-02S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Text instructions', 'description': 'Medication instructions displayed in text format'}, {'type': 'EXPERIMENTAL', 'label': 'Drug indication icons', 'description': 'Icons illustrate the purpose of each medication', 'interventionNames': ['Behavioral: Drug indication icons']}, {'type': 'EXPERIMENTAL', 'label': 'Structured instructions', 'description': 'Graphical format shows what time(s) of day each medication should be taken', 'interventionNames': ['Behavioral: Structured instructions']}, {'type': 'EXPERIMENTAL', 'label': 'Icons + Structured instructions', 'description': 'Icons illustrate the purpose of each medication, and a graphical format shows what time(s) of day each medication should be taken', 'interventionNames': ['Behavioral: Drug indication icons', 'Behavioral: Structured instructions']}], 'interventions': [{'name': 'Drug indication icons', 'type': 'BEHAVIORAL', 'description': 'Icons illustrate the purpose of each medication', 'armGroupLabels': ['Drug indication icons', 'Icons + Structured instructions']}, {'name': 'Structured instructions', 'type': 'BEHAVIORAL', 'description': 'Graphical format shows what time(s) of day each medication should be taken', 'armGroupLabels': ['Icons + Structured instructions', 'Structured instructions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37209', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Saint Thomas Family Health Center - West', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37211', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Saint Thomas Family Health Center - South', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'M Brian Riley, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PictureRx, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PictureRx, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research', 'investigatorFullName': 'M Brian Riley', 'investigatorAffiliation': 'PictureRx, LLC'}}}}