Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-29 @ 11:49 PM
Study NCT ID:
NCT01977495
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2013-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Take Charge of Your Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-07', 'studyFirstSubmitDate': '2013-10-24', 'studyFirstSubmitQcDate': '2013-10-30', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Hemoglobin A1c', 'timeFrame': 'End of study- 6 months after enrollment', 'description': 'Assess how regular use of home-based health monitoring devices affects clinical outcomes, such as Hemoglobin A1C'}], 'primaryOutcomes': [{'measure': 'Enrollment and participation rates', 'timeFrame': 'End of study- 6 months after enrollment', 'description': 'The primary objective is to obtain preliminary evidence regarding whether or not patients opt-into a research study, as opposed to enrolling by default, will affect participation in the program and the effectiveness of the intervention, among high-risk patients. The primary outcome is to measure enrollment rates. The investigators will also measure participation in the program through device usage.'}], 'secondaryOutcomes': [{'measure': 'Uptake of Device Usage', 'timeFrame': 'End of study- 6 months after enrollment', 'description': 'Assess the effect of financial incentives on the use of home health monitoring devices among high-risk patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Enrollment methods', 'Behavioral Economic Intervention', 'Opt-in Enrollment', 'Opt-out Enrollment', 'lottery', 'financial incentives'], 'conditions': ['Diabetes', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The investigator plans to assess enrollment rates among two different enrollment methods, while providing a behavioral economic intervention to enhance the uptake of home-health monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. The study is focusing on enrollment methods since the standard randomized control trial only reaches 15% of the population. The study is seeking to understand the effectiveness of a behavioral intervention, when rolled out in a larger population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults between 18 and 80 years of age\n2. Primary care patients at the Division of General Internal Medicine clinics at the University of Pennsylvania\n3. Hemoglobin A1c measured within the last 8 weeks greater than 8.0% OR no measured Hemoglobin A1C measured in the last two years\n4. A confirmed diabetes diagnosis\n5. Planning to stay in area for study duration (6 months)\n6. Can understand and communicate fluently in English\n\nExclusion Criteria:\n\n1. Unable to read and give consent\n2. Suffer from an uncontrolled psychiatric disease'}, 'identificationModule': {'nctId': 'NCT01977495', 'briefTitle': 'Take Charge of Your Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Testing Enrollment Methods on Participation in Behavioral Economic Interventions for Diabetes Care: A Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': '818810'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Opt-in Enrollment', 'description': 'Opt-in enrollment: patient will be sent a recruitment letter, in which they must call the study team to take part in the study. During that call, the study team will schedule the participant for an intake visit.', 'interventionNames': ['Behavioral: Financial Incentive: Fixed Lottery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opt-out enrollment', 'description': "Opt-out enrollment: patient will be sent a letter communicating to them that they have been enrolled into a research program at their doctor's office. After 10 days, the study team will contact the opt-out participants to schedule an intake visit.", 'interventionNames': ['Behavioral: Financial Incentive: Fixed Lottery']}], 'interventions': [{'name': 'Financial Incentive: Fixed Lottery', 'type': 'BEHAVIORAL', 'description': 'Every day of the 91 day intervention period participants will be asked to use each of their biometric devices. A daily lottery will be conducted automatically by the study website. Participants must use each of their two devices daily to be eligible for the lottery the following day. Winning lottery numbers will be identified by a fixed-position match between the automatically generated winning number and a participant ID number, which each participant will pick at enrollment.', 'armGroupLabels': ['Opt-in Enrollment', 'Opt-out enrollment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jaya Aysola, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jaya Aysola', 'investigatorAffiliation': 'University of Pennsylvania'}}}}