Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-03-23 @ 4:46 PM
Study NCT ID:
NCT00649766
Status:
UNKNOWN
Last Update Posted:
2008-04-01
First Post:
2008-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tailored Messages to Increase Eye Examination Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-11-21', 'releaseDate': '2017-10-18'}], 'estimatedResultsFirstSubmitDate': '2017-10-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2008-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-03-28', 'studyFirstSubmitDate': '2008-03-28', 'studyFirstSubmitQcDate': '2008-03-28', 'lastUpdatePostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'doctor-confirmed dilated eye examination', 'timeFrame': '3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tailored health messages', 'glaucoma', 'diabetic retinopathy', 'dilated fundus exams', 'health behavior'], 'conditions': ['Eye Disease', 'Eye Care']}, 'referencesModule': {'references': [{'pmid': '17460251', 'type': 'RESULT', 'citation': 'Ellish NJ, Royak-Schaler R, Passmore SR, Higginbotham EJ. Knowledge, attitudes, and beliefs about dilated eye examinations among African-Americans. Invest Ophthalmol Vis Sci. 2007 May;48(5):1989-94. doi: 10.1167/iovs.06-0934.'}, {'pmid': '22159679', 'type': 'DERIVED', 'citation': 'Ellish NJ, Royak-Schaler R, Higginbotham EJ. Tailored and targeted interventions to encourage dilated fundus examinations in older African Americans. Arch Ophthalmol. 2011 Dec;129(12):1592-8. doi: 10.1001/archophthalmol.2011.190.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to test two different types of health messages, one that is developed for a specific group (targeted) and the other that is more personalized to individuals (tailored), to see which is better at changing how often people have their eyes examined. We hypothesize that people who get the tailored messages will be more likely to get a dilated eye exam than people who receive the targeted messages.', 'detailedDescription': 'Studies have shown that people are not getting their eyes examined on a regular basis, even though dilated eye exams can detect eye diseases like glaucoma and diabetic retinopathy early, before significant vision loss has developed. Early detection can lead to earlier treatment, which can save sight by preventing or slowing the progression of these eye diseases. In this project we designed, implemented, and are now evaluating tailored and targeted print health messages to increase eye examination behavior in an African-American population 65 years of age and older, a group at increased risk of glaucoma and diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African-American\n* 65 years of age or older\n* no dilated fundus exam in past 2 years\n\nExclusion Criteria:\n\n* appointment for dilated fundus exam scheduled\n* no access to phone'}, 'identificationModule': {'nctId': 'NCT00649766', 'briefTitle': 'Tailored Messages to Increase Eye Examination Behavior', 'organization': {'class': 'NIH', 'fullName': 'National Eye Institute (NEI)'}, 'officialTitle': 'Tailored Messages to Increase Eye Examination Behavior', 'orgStudyIdInfo': {'id': 'R01EY015899', 'link': 'https://reporter.nih.gov/quickSearch/R01EY015899', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01EY015899', 'link': 'https://reporter.nih.gov/quickSearch/R01EY015899', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'tailored print messages to encourage eye examination behavior', 'interventionNames': ['Behavioral: tailored newsletter']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'targeted print messages to encourage eye examination behavior', 'interventionNames': ['Behavioral: targeted newsletter']}], 'interventions': [{'name': 'tailored newsletter', 'type': 'BEHAVIORAL', 'description': "Tailored newsletter that addresses each person's stage of change, barriers to getting eye exams, and knowledge of eye exams and eye disease", 'armGroupLabels': ['1']}, {'name': 'targeted newsletter', 'type': 'BEHAVIORAL', 'description': 'Targeted newsletter that contains messages about barriers to getting eye exams and presents facts about glaucoma and African-Americans.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Nancy J. Ellish, DrPH, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Eye Institute (NEI)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Nancy Ellish', 'oldOrganization': 'University of Maryland, Baltimore'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-10-18', 'type': 'RELEASE'}, {'date': '2017-11-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'National Eye Institute (NEI)'}}}}