Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-04-09 @ 12:29 PM
Study NCT ID:
NCT02746861
Status:
UNKNOWN
Last Update Posted:
2016-04-21
First Post:
2016-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peer-Supported Diabetes Self-Management Support
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2016-04-19', 'studyFirstSubmitQcDate': '2016-04-19', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average reduction in HbA1c from baseline', 'timeFrame': '6-months'}]}, 'conditionsModule': {'keywords': ['peer mentor', 'peer supporter', 'peer coach', 'peer-to-peer mentoring'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The objective is to evaluate the efficacy of a web-trained workforce of Hispanic and African American diabetes peer mentors delivering Diabetes Self-Management Support (DSMS) to patients with poorly-controlled diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* HbA1c\\>9%\n* African American or Hispanic ethnicity'}, 'identificationModule': {'nctId': 'NCT02746861', 'acronym': 'DSMS', 'briefTitle': 'Peer-Supported Diabetes Self-Management Support', 'organization': {'class': 'OTHER', 'fullName': 'InquisitHealth, Inc.'}, 'officialTitle': 'Web-based Training of Peers to Deliver Diabetes Self-Management Support', 'orgStudyIdInfo': {'id': 'DSMS24'}, 'secondaryIdInfos': [{'id': '5R43MD009555', 'link': 'https://reporter.nih.gov/quickSearch/5R43MD009555', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetes Self-Management Support (DSMS)', 'description': 'Patient receives 6-months of DSMS while receiving support from a trained peer mentor (Peer-supported DSMS).', 'interventionNames': ['Behavioral: Peer-Supported DSMS']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Patient continues to receive usual care.'}], 'interventions': [{'name': 'Peer-Supported DSMS', 'type': 'BEHAVIORAL', 'description': 'Phone, SMS/text, and smartphone-based intervention.', 'armGroupLabels': ['Diabetes Self-Management Support (DSMS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07661', 'city': 'River Edge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashwin Patel', 'role': 'CONTACT', 'phone': '855-412-1787'}], 'facility': 'InquisitHealth', 'geoPoint': {'lat': 40.92871, 'lon': -74.03986}}], 'centralContacts': [{'name': 'Ashwin Patel, MD PhD', 'role': 'CONTACT', 'phone': '855-412-1787'}], 'overallOfficials': [{'name': 'Ashwin Patel, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief Medical Officer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InquisitHealth, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Medical Officer', 'investigatorFullName': 'Ashwin Patel', 'investigatorAffiliation': 'InquisitHealth, Inc.'}}}}