Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-30 @ 3:30 PM
Study NCT ID:
NCT00753857
Status:
COMPLETED
Last Update Posted:
2008-09-17
First Post:
2008-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-16', 'studyFirstSubmitDate': '2008-09-16', 'studyFirstSubmitQcDate': '2008-09-16', 'lastUpdatePostDateStruct': {'date': '2008-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of two drugs for the same indication, Knowledge and judgments about 2 drugs to reduce the future risk of cardiovascular events', 'timeFrame': 'Immediate return of patient survey'}], 'secondaryOutcomes': [{'measure': 'Comprehension of information contained in the drug facts box', 'timeFrame': 'Immediate return of patient survey'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['risk communication', 'probability sample by random digit dialing'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'RATIONALE:\n\nThe way in which information about a drug is provided may affect the ability of patients and doctors to understand how a drug works and the side effects of the drug.\n\nPURPOSE:\n\nThis randomized trial is studying how well a drug facts page works compared with a short drug summary in helping patients and doctors understand medical information.', 'detailedDescription': 'This is a randomized study. Participants are contacted by phone via random-digit dialing for initial interview using the computer-assisted telephone interviewing (CATI) system. Eligible participants are then randomized to 1 of 2 intervention arms.\n\n* Compare the effect of a prescription drug summary (one-page summary of drug information that includes a table with data on drug benefit and side effects) vs standard brief summary in direct-to-consumer advertisements on the comparisons of two drugs for the same indication, knowledge of drug efficacy and side effects of each drug, perceptions of drug efficacy and side effects of each drug\n* Comprehension of information contained in the drug facts box'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 35-70 year old in household selected by random digit dialing\n\nExclusion Criteria:\n\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT00753857', 'briefTitle': 'The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction', 'organization': {'class': 'FED', 'fullName': 'White River Junction Veterans Affairs Medical Center'}, 'officialTitle': 'The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction', 'orgStudyIdInfo': {'id': 'DMS-15879-2'}, 'secondaryIdInfos': [{'id': 'NCT00386932'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants received 2 ads for drugs to reduce cardiovascular risk with drug facts boxes second pages.', 'interventionNames': ['Other: Drug Facts Box']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participants receive the same 2 advertisements for drugs to reduce cardiovascular risk with the standard second page (i.e., brief summary)', 'interventionNames': ['Other: Standard Brief Summary']}], 'interventions': [{'name': 'Drug Facts Box', 'type': 'OTHER', 'description': 'Educational intervention of 1 page summary of drug efficacy and side effects', 'armGroupLabels': ['1']}, {'name': 'Standard Brief Summary', 'type': 'OTHER', 'description': 'Ads consisted of the standard second page called the brief summary', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05009', 'city': 'White River Junction', 'state': 'Vermont', 'country': 'United States', 'facility': 'VA Medical Center', 'geoPoint': {'lat': 43.64896, 'lon': -72.31926}}], 'overallOfficials': [{'name': 'Steven Woloshin, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth Medical School; VA Medical Center (WRJ)'}, {'name': 'Lisa M Schwartz, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth Medical School, VA Medical Center (WRJ)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'White River Junction Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Lisa Schwartz', 'oldOrganization': 'VA Outcomes Group'}}}}