Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-25 @ 12:45 PM
Study NCT ID:
NCT00799695
Status:
COMPLETED
Last Update Posted:
2008-12-01
First Post:
2008-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetic Retina Exam Rate Does Not Increase With Phone Reminders in Non-HMO Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 561}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-28', 'studyFirstSubmitDate': '2008-11-26', 'studyFirstSubmitQcDate': '2008-11-28', 'lastUpdatePostDateStruct': {'date': '2008-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a change in the proportion of diabetic patients who acted as a result of the phone contact, and obtained a retina eye exam.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetic retinopathy', 'screening', 'annual'], 'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'Diabetic retinopathy is the major cause of blindness in working age Americans, and screening for it is cost-effective. There are a quarter of a million people in Southeast Michigan with diabetes and pre-diabetes.\n\nOnly half of patients with diabetes are screened regularly for diabetic retinopathy, and this proportion has been difficult to increase despite various interventions. Previous research focused on HMO patient groups because preventative care was thought to decrease plan costs. In addition, it was administratively feasible to track patient-doctor interactions.\n\nThis project builds on published research and institutional experience to determine an effective method for increasing the screening rate, in a mobile, non-HMO population. It uses administrative methods and information technology infrastructures, such as large scale electronic medical records and patient demographic databases, to identify existing patients requiring examinations.\n\nPatients were telephoned by a trained service representative who offered and scheduled firm examination appointment times.\n\nHypothesis: Annual screening rates for diabetic retinopathy can be substantially improved in non-HMO patient groups by directly contacting patients and scheduling firm appointment times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* were Henry Ford Health System patients,\n* diabetic\n* using the BCBSM payer plan\n\nExclusion Criteria:\n\n* retina examination in prior year'}, 'identificationModule': {'nctId': 'NCT00799695', 'briefTitle': 'Diabetic Retina Exam Rate Does Not Increase With Phone Reminders in Non-HMO Population', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Diabetic Retina Exam Rate Does Not Increase With Phone Reminders in Non-HMO Population', 'orgStudyIdInfo': {'id': 'F10030'}, 'secondaryIdInfos': [{'id': 'F10030'}, {'id': '13.13PIRAP'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'phone call contact', 'type': 'BEHAVIORAL', 'description': 'A sample of subjects who had not completed their annual diabetic screening exams were contacted by phone and offered appointments for eye exams'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Robert M Levine,, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blue Cross Blue Shield of Michigan Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Robert M. Levine, MD', 'oldOrganization': 'Henry Ford Health System'}}}}