Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-10 @ 11:38 PM
Study NCT ID:
NCT02137720
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2014-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translating Telephonic Diabetes Self-management Support to Primary Care Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], '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': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 812}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-24', 'studyFirstSubmitDate': '2014-05-08', 'studyFirstSubmitQcDate': '2014-05-09', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Change from baseline at 12 months', 'description': 'Obtained from electronic medical record.'}], 'secondaryOutcomes': [{'measure': 'Diabetes Self-Management', 'timeFrame': 'Change from baseline at 12 months', 'description': 'Measured by self-report questionnaire'}, {'measure': 'Medication Adherence', 'timeFrame': 'Change from baseline at 12 months', 'description': 'Measured by self-report questionnaire'}, {'measure': 'Diabetes-related distress', 'timeFrame': 'Change from baseline at 12 months', 'description': 'Measured by self-report questionnaire'}, {'measure': 'Depressive symptoms', 'timeFrame': 'Change from baseline at 12 months', 'description': 'Measured by self-report questionnaire'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline and 12 months', 'description': 'Obtained from electronic medical record.'}, {'measure': 'Cholesterol', 'timeFrame': 'Baseline and 12 months', 'description': 'Obtained from electronic medical record.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Treatment Adherence', 'Self-management', 'Emotional Distress', 'Diabetes-related Distress'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '33022367', 'type': 'DERIVED', 'citation': 'Gonzalez JS, Hoogendoorn CJ, Linnell J, Fishman S, Jonas V, Pham-Singer H, Schechter CB, Walker EA, Wu WY. Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support. Contemp Clin Trials. 2020 Nov;98:106166. doi: 10.1016/j.cct.2020.106166. Epub 2020 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the implementation and effectiveness of an intervention to improve diabetes self-management, emotional distress and metabolic control among adults with type 2 diabetes receiving care in primary care practices throughout New York City. The program will be implemented by the New York City Department of Health, through their Primary Care Improvement Project.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 21 years of age and older\n* Receiving treatment for diabetes at selected primary care practices throughout New York City\n* Most recent HbA1c ≥ 7.5% (max 3 months prior to randomization)\n* Ability to speak and read English or Spanish (or someone in the household who will read to them)\n* Access to a telephone\n* Willing to give informed consent to participate and accept random assignment.\n\nExclusion Criteria:\n\n* Stated intention to move out of the New York City area during the next year\n* Mental incapacity (e.g., confusion) evident on first telephone contact by Department of Health staff\n* Treatment provider deems that the patient is inappropriate for the trial'}, 'identificationModule': {'nctId': 'NCT02137720', 'briefTitle': 'Translating Telephonic Diabetes Self-management Support to Primary Care Practice', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Translating Telephonic Diabetes Self-management Support to Primary Care Practice: The NYC Care Calls Trial', 'orgStudyIdInfo': {'id': '2012-422'}, 'secondaryIdInfos': [{'id': '1R18DK098742-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R18DK098742-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telephonic Diabetes Self-Management Support', 'description': 'This group receives all the Educational Print Materials received by the comparison condition plus telephone calls from a health educator to provide tailored diabetes self-management training and support. Participants with significant emotional distress at baseline also receive additional calls focused on distress management.', 'interventionNames': ['Behavioral: Telephonic Diabetes Self-Management Support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational Print Materials', 'description': 'Participants randomized to this arm will receive print materials on diabetes, glycemic control, self-management, and distress/depression.', 'interventionNames': ['Other: Educational Print Materials']}], 'interventions': [{'name': 'Telephonic Diabetes Self-Management Support', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Telephonic Diabetes Self-Management Support']}, {'name': 'Educational Print Materials', 'type': 'OTHER', 'armGroupLabels': ['Educational Print Materials']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11101', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York City Department of Health and Mental Hygiene', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jeffrey S Gonzalez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}, {'name': 'Winfred Y Wu, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York City Department of Health and Mental Hygiene'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'New York City Department of Health and Mental Hygiene', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jeffrey Gonzalez', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}