Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-03-08 @ 11:44 PM
Study NCT ID:
NCT02036892
Status:
UNKNOWN
Last Update Posted:
2014-01-15
First Post:
2014-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronically Connected Health Coaching in Type 2 Diabetes
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'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-13', 'studyFirstSubmitDate': '2014-01-06', 'studyFirstSubmitQcDate': '2014-01-13', 'lastUpdatePostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': '6 months follow up from baseline', 'description': 'Finger prick A1c test or lab test'}], 'secondaryOutcomes': [{'measure': 'Center for Epidemiological Studies Depression Scale', 'timeFrame': '6 months follow up from baseline assessment', 'description': 'Self report measure of psychological distress'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '26441467', 'type': 'DERIVED', 'citation': 'Wayne N, Perez DF, Kaplan DM, Ritvo P. Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial. J Med Internet Res. 2015 Oct 5;17(10):e224. doi: 10.2196/jmir.4871.'}, {'pmid': '26199275', 'type': 'DERIVED', 'citation': 'Pludwinski S, Ahmad F, Wayne N, Ritvo P. Participant experiences in a smartphone-based health coaching intervention for type 2 diabetes: A qualitative inquiry. J Telemed Telecare. 2016 Apr;22(3):172-8. doi: 10.1177/1357633X15595178. Epub 2015 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better Hemoglobin A1c levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the control arm (health coaching alone).', 'detailedDescription': 'Inclusion criteria: all participating patients have been diagnosed with Type 2 Diabetes, are between 25 and 70 years of age, have a regular primary care physician, and have HbA1c levels \\> or = to 7.3.\n\nExclusion criteria: Axis I and II psychiatric disorders.\n\nPrimary outcome: HBA1c at 6 months follow up.\n\nSecondary outcome: Centre for Epidemiological Studies Depression Scale'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Type 2 Diabetes\n* Fluency in English and/or Spanish\n\nExclusion Criteria:\n\n* \\> 75 years of age'}, 'identificationModule': {'nctId': 'NCT02036892', 'briefTitle': 'Electronically Connected Health Coaching in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'York University'}, 'officialTitle': 'Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial', 'orgStudyIdInfo': {'id': '13-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle counseling with smartphones', 'description': 'Lifestyle counseling assisted by smartphones', 'interventionNames': ['Behavioral: Lifestyle counseling with smartphone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lifestyle counseling', 'description': 'Lifestyle counseling', 'interventionNames': ['Behavioral: Lifestyle counseling']}], 'interventions': [{'name': 'Lifestyle counseling with smartphone', 'type': 'BEHAVIORAL', 'description': 'Lifestyle counseling with health promoting smartphone software', 'armGroupLabels': ['Lifestyle counseling with smartphones']}, {'name': 'Lifestyle counseling', 'type': 'BEHAVIORAL', 'description': 'Lifestyle counseling', 'armGroupLabels': ['Lifestyle counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M3M1A4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Paul Ritvo, PhD', 'role': 'CONTACT', 'email': 'pritvo@yorku.ca', 'phone': '4165808021'}, {'name': 'Noah Wayne, MSc', 'role': 'CONTACT', 'email': 'NoahWayne@gmail.com', 'phone': '4168897289'}, {'name': 'Noah Wayne, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Black Creek Community Health Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Paul Ritvo, PhD', 'role': 'CONTACT', 'email': 'pritvo@yorku.ca', 'phone': '4165808021'}, {'name': 'Noah Wayne, MSc', 'role': 'CONTACT', 'email': 'noahwayne@gmail.com', 'phone': '4168897289'}], 'overallOfficials': [{'name': 'Paul Ritvo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'York University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'York University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health Agency of Canada (PHAC)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, School of Kinesiology and Health Science', 'investigatorFullName': 'Paul Ritvo', 'investigatorAffiliation': 'York University'}}}}