Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-24 @ 11:14 PM
Study NCT ID:
NCT06587204
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2024-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding Decentralized Trial Engagement and Clinical Impediments Through Digital Efforts (UDECIDE) Among Unrepresented Groups With Poor Cardiovascular and Cardiometabolic Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2024-09-04', 'studyFirstSubmitQcDate': '2024-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants adhering to the intervention', 'timeFrame': '3 months', 'description': 'Will be measured in percentage'}, {'measure': 'Percentage of participants retained in the intervention', 'timeFrame': '3 months', 'description': 'Will be measured in percentage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Diseases']}, 'descriptionModule': {'briefSummary': 'The objective of the UDECIDE study is to demonstrate adherence to decentralized clinical trials among underrepresented groups with cardiometabolic conditions .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of pre-diabetes/diabetes and/or pre-hypertension/hypertension\n* History of Cardiometabolic risk factors including the following: hypertension, Coronary Artery Disease (CAD), heart attack, heart failure, stroke, atherosclerosis, arrhythmias, Peripheral Artery Disease (PAD), type 2 diabetes, metabolic syndrome, obesity, dyslipidemia, insulin resistance, or elevated cholesterol.\n* Identify as Black or non-White Hispanic\n* Own a smart phone\n\nExclusion Criteria:\n\n* Does not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06587204', 'briefTitle': 'Understanding Decentralized Trial Engagement and Clinical Impediments Through Digital Efforts (UDECIDE) Among Unrepresented Groups With Poor Cardiovascular and Cardiometabolic Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Understanding Decentralized Trial Engagement and Clinical Impediments Through Digital Efforts (UDECIDE) Among Unrepresented Groups With Poor Cardiovascular and Cardiometabolic Health', 'orgStudyIdInfo': {'id': '20240230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control Group', 'description': 'Participants in this group will be receiving the standard of care for up to 3 months.', 'interventionNames': ['Other: Control Group']}, {'type': 'EXPERIMENTAL', 'label': 'Decentralized Group', 'description': 'Participants in this group will be receiving the decentralized intervention for up to 3 months.', 'interventionNames': ['Behavioral: Decentralized Group']}, {'type': 'EXPERIMENTAL', 'label': 'Digital Literacy Navigation Group', 'description': 'Participants in this group will be receiving the Digital Literacy Navigation intervention for up to 3 months.', 'interventionNames': ['Behavioral: Decentralized Group', 'Behavioral: Digital Literacy Navigation Group']}, {'type': 'EXPERIMENTAL', 'label': 'Social Care Navigation Group', 'description': 'Participants in this group will be receiving the Social Care Navigation intervention for up to 3 months.', 'interventionNames': ['Behavioral: Decentralized Group', 'Behavioral: Digital Literacy Navigation Group', 'Behavioral: Social Care Navigation Group']}], 'interventions': [{'name': 'Control Group', 'type': 'OTHER', 'description': 'Participants will receive standard of care.', 'armGroupLabels': ['Control Group']}, {'name': 'Decentralized Group', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a one time digital lifestyle management program that will be used for the rest of the intervention. The Digital lifestyle management program is a virtual application that manages nutrition, exercise, and sleep. Participants will be using the application at least 1 hour each day.', 'armGroupLabels': ['Decentralized Group', 'Digital Literacy Navigation Group', 'Social Care Navigation Group']}, {'name': 'Digital Literacy Navigation Group', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a one time digital literacy training virtual learning digital health education for the rest of the intervention . The digital literacy training is a digital health education program that will be given 1 hour a day for 3 weeks.', 'armGroupLabels': ['Digital Literacy Navigation Group', 'Social Care Navigation Group']}, {'name': 'Social Care Navigation Group', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a one time social care navigation application that will be used for the rest of the intervention. The Social Care Navigation application is a digital application that provides social care resources in the community to participants. The application is used 1 hour a day, each day.', 'armGroupLabels': ['Social Care Navigation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carolina Scaramutti, PhD', 'role': 'CONTACT', 'email': 'cscaramutti@med.miami.edu', 'phone': '(305) 243-3797'}, {'name': 'Stacyca Dimanche, BS', 'role': 'CONTACT', 'email': 'syd1755@med.miami.edu', 'phone': '(305) 243-3797'}, {'name': 'Azizi A Seixas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Carolina Scaramutti, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Carolina Scaramutti, PhD', 'role': 'CONTACT', 'email': 'cscaramutti@med.miami.edu', 'phone': '305-243-1298'}], 'overallOfficials': [{'name': 'Azizi Seixas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Azizi Seixas', 'investigatorAffiliation': 'University of Miami'}}}}