Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT01125956
Status:
COMPLETED
Last Update Posted:
2019-02-28
First Post:
2010-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Diabetes Control Through Peer Counseling and Incentives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2010-05-17', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': 'Baseline, 6 months', 'description': 'Change in HbA1c from baseline will be the primary outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Counts of the number of hypoglycemic events', 'timeFrame': '6 months', 'description': 'All events and serious events related to hypoglycemia will be counted over the 6 month intervention period, including emergency room visits and hospitalizations.'}, {'measure': 'Number of peer encounters', 'timeFrame': '6 months', 'description': 'The number of peer encounters by arm will be described.'}, {'measure': 'Experience of peer counseling', 'timeFrame': '6 months', 'description': 'The experience of peer counseling from both poorly controlled diabetics and counselors will be described.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Diabetes mellitus', 'HbA1c'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '22431674', 'type': 'DERIVED', 'citation': 'Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):416-24. doi: 10.7326/0003-4819-156-6-201203200-00004.'}], 'seeAlsoLinks': [{'url': 'http://www.med.upenn.edu/ldichi/', 'label': 'LDI Center for Health Incentives'}, {'url': 'https://www.cherp.research.va.gov/', 'label': 'VA Center for Health Equity and Promotion (CHERP)'}, {'url': 'https://grants.nih.gov/grants/guide/rfa-files/RFA-AG-09-005.html', 'label': 'This research was supported by a grant from the National Institute on Aging, P30-AG036592. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute on Aging or the NIH'}]}, 'descriptionModule': {'briefSummary': 'The specific aims of this study are to test whether in a cohort of low-income minority veterans with poor diabetes mellitus (DM) control:\n\n1. Peer counseling is an effective means of reducing HbA1c (a measure of glucose control).\n2. Financial incentives are an effective means of reducing HbA1c. This is a randomized controlled pilot study. There will be 3 arms: 1) a control group of poorly controlled diabetics getting usual care; 2) peer counseling with no incentives; and 3) financial incentives without peers. Ultimately, contingent on the success of this intervention, the researchers plan to apply for funding for a large scale intervention employing both peer counseling and incentives to improve DM control in low income and minority patients who are at high risk for premature morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American veteran\n* 50-70 years old\n* ICD-9CM diagnosis code consistent with DM (any ICD-9CM code starting with 250)\n* For patients: last two HbA1c greater than 8% with at least one measure being within 3 months of enrollment\n* For peer counselors: HbA1c of greater than 8% in the past 3 years and an HbA1c less than or equal to 7.5% within 3 months of enrollment\n\nExclusion Criteria:\n\n* Unstable medical condition that would likely prevent the subject from completing the study\n* Patients enrolled in Telehealth will be excluded as such enrollment does not constitute usual care'}, 'identificationModule': {'nctId': 'NCT01125956', 'briefTitle': 'Improving Diabetes Control Through Peer Counseling and Incentives', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Improving Diabetes Control Through Peer Counseling and Incentives', 'orgStudyIdInfo': {'id': '01164'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group will receive usual diabetes care through their primary care clinicians.'}, {'type': 'EXPERIMENTAL', 'label': 'Peer counseling', 'description': 'A peer counselor will be assigned to each participant who currently has good diabetes control but had poor control in the past 3 years.', 'interventionNames': ['Behavioral: Assigned a peer counselor']}, {'type': 'EXPERIMENTAL', 'label': 'Financial incentives', 'description': 'Patient participants in the financial incentive arm will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points.', 'interventionNames': ['Behavioral: Financial incentives']}], 'interventions': [{'name': 'Assigned a peer counselor', 'type': 'BEHAVIORAL', 'description': 'Dyads will be given $20 per month if they have contact 4 or more times during a month.', 'armGroupLabels': ['Peer counseling']}, {'name': 'Financial incentives', 'type': 'BEHAVIORAL', 'description': 'Participants will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points.', 'armGroupLabels': ['Financial incentives']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Philadelphia Veterans Affairs Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Judith Long, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}