Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-03-08 @ 1:06 AM
Study NCT ID:
NCT04949568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2021-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-Management and Glycemic Control in Adult Haitian Immigrants With 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': 'D010358', 'term': 'Patient Participation'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Both conditions will receive standard care. We will use sequentially numbered opaque sealed envelopes to conceal the allocation determination'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Behavioral: Diabetes Self-management behaviors'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summary of Diabetes of Self-Care Activities Scale (11- item)', 'timeFrame': '(T0) baseline through (T3) 90 days post-intervention', 'description': 'Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)'}, {'measure': 'Stanford Diabetes Self-Efficacy Scale (8- item)', 'timeFrame': '(T0) baseline through (T3) 90 days post-intervention', 'description': 'Change in general self-efficacy 1-10, higher scores indicate improvement)'}, {'measure': 'Wrist-worn actigraphy (ActiGraph) to be worn while awake', 'timeFrame': '(T0) baseline through (T3) 90 days post-intervention', 'description': 'Change in physical activity (Frequent physical activity indicates improvement)'}, {'measure': 'Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro', 'timeFrame': '(T0) baseline through (T3) 90 days post-intervention', 'description': 'Time in range and glucose variability (More time in range and less glucose variability indicates improvement)'}], 'secondaryOutcomes': [{'measure': 'Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6', 'timeFrame': '(T0) baseline through (T3) 90 days post-intervention', 'description': 'Change in diabetes distress ( 0-6, lower scores indicates improvement)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immigrant Health', 'Diabetes Mellitus, Type 2', 'Metabolic Diseases', 'Self-Management Behaviors', 'Haitian Americans'], 'conditions': ['Diabetes Mellitus, Type 2', 'Patient Engagement', 'Patient Education']}, 'referencesModule': {'references': [{'pmid': '34610761', 'type': 'BACKGROUND', 'citation': 'Magny-Normilus C, Whittemore R, Wexler DJ, Schnipper JL, Nunez-Smith M, Fu MR. Barriers to Type 2 Diabetes Management Among Older Adult Haitian Immigrants. Sci Diabetes Self Manag Care. 2021 Oct;47(5):382-390. doi: 10.1177/26350106211040435.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult Haitian immigrants.', 'detailedDescription': "This is a two-arm randomized trial. Participants will be randomized to the culturally tailored Diabetes Self-Management Education Program or standard care condition in a 1:1 allocation. All participants will receive standard type 2 diabetes care at the enrolled clinic and remain under their providers' care for the duration of the study. The culturally tailored Diabetes Education Program involves the following: 1) an initial 45-minute face-to-face consultation; and 2) six 2-hour weekly interactive educational sessions in a format to be determined (TBD) by Aim 1 (e.g., in-person, video/telephone conference call)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-described Haitian immigrant aged 21 and older\n* Known diagnosis of type 2 diabetes for at least one year\n* Have lived in the US for at least one year\n* Have an HbA1c of 7.5%\n* Willing and able to participate in an individual interview\n\nExclusion Criteria:\n\n* Having a diagnosis of type 1 diabetes\n* Unable to comprehend, consent and or fully participate in the study'}, 'identificationModule': {'nctId': 'NCT04949568', 'briefTitle': 'Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'New York University'}, 'officialTitle': 'Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes: A Pilot Randomized Study', 'orgStudyIdInfo': {'id': '2024-9103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetes Self-Management Behaviors', 'description': 'Self-Management Education Program The culturally tailored Diabetes Self-Management Education Program involves the following: 1) an initial 45-minute face-to-face private consultation collaboratively determining goals; followed by 2) six 2-hour weekly educational interactive sessions in a format TBD by aim 1. We will deliver culturally targeted written materials and presentations in these sessions. Participants will be asked to practice self-management behaviors concurrently and for four additional weeks.', 'interventionNames': ['Behavioral: Diabetes Self-Management Behaviors']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Type 2 Diabetes Care', 'description': "The usual care arm will receive the clinic's standard type 2 diabetes care and remain under their providers' care for the duration of the study."}], 'interventions': [{'name': 'Diabetes Self-Management Behaviors', 'type': 'BEHAVIORAL', 'description': 'The intervention is to be delivered by an interventionist.', 'armGroupLabels': ['Diabetes Self-Management Behaviors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Cherlie Magny-Normilus, PhD, FNP-BC, FAAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}