Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-26 @ 9:01 AM
Study NCT ID:
NCT06283992
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2024-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Health Navigation for Latino Patients With Type II Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Researchers will compare effectiveness between two arms: 1) patient education using a digital navigator on using digital tools after discharge and 2) usual care (educational sheet).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Who Login to the Portal', 'timeFrame': '30 days post-discharge', 'description': 'Number of participants with at least 1 login to the portal in the 30 days after discharge'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants that Perform Distinct Portal Functions', 'timeFrame': '30 days post-discharge', 'description': 'Proportion of participants that perform distinct portal functions (sending messages, requesting refill)'}, {'measure': 'Proportion of participants that complete a telehealth', 'timeFrame': '30 days post-discharge', 'description': 'Proportion of participants that complete a telehealth visit during post-discharge period'}, {'measure': 'Proportion of participants that are re-admitted', 'timeFrame': '30 days post-discharge', 'description': 'Proportion of participants that are re-admitted within 30 days after discharge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Latinos'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '36795062', 'type': 'BACKGROUND', 'citation': 'Rodriguez JA, Charles JP, Bates DW, Lyles C, Southworth B, Samal L. Digital healthcare equity in primary care: implementing an integrated digital health navigator. J Am Med Inform Assoc. 2023 Apr 19;30(5):965-970. doi: 10.1093/jamia/ocad015.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge.', 'detailedDescription': 'Latinos have the second-highest age-adjusted prevalence and among the highest incidence of diabetes. Latinos also experience worse glycemic control and diabetes-related complications, including diabetic retinopathy and chronic renal disease. These findings are concerning since Latinos are the largest minority group in the U.S and will account for 25% of the population by 2045.\n\nDigital tools, like patient portals and telemedicine, offer an opportunity to address some of the challenges that lead to these disparities, especially during care transitions. However, Latinos, especially those who are Spanish-speaking are less likely to use digital health tools. Findings from previous health information technology work have highlighted barriers, including 1) digital access and literacy, 2) interface usability, 3) privacy, and 4) patient preference. One promising intervention to address digital literacy gaps is the use digital navigators.\n\nThis study aims are to assess a digital health navigation intervention focused on increasing patient portal use after discharge among Latino patients with type II diabetes admitted to the general medicine inpatient floor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Self-identified Latino adult patients with type II diabetes\n* Admitted to general medicine floors at Brigham and Women's Hospital\n* Preferred language: English or Spanish\n\nExclusion Criteria:\n\n* Critical illness\n* dementia, delirium, or other condition that limits ability to participate in education and consent process"}, 'identificationModule': {'nctId': 'NCT06283992', 'briefTitle': 'Digital Health Navigation for Latino Patients With Type II Diabetes', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Digital Health Navigation for Latino Patients With Type II Diabetes: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2024p000095'}, 'secondaryIdInfos': [{'id': 'K23MD016439', 'link': 'https://reporter.nih.gov/quickSearch/K23MD016439', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Navigation', 'description': 'Patients in this arm will receive 1:1 digital navigation support which will teach them about the functions of the patient portal and telehealth.', 'interventionNames': ['Other: Digital Navigation']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Patients in this arm will receive the standard of care which will be an educational sheet.'}], 'interventions': [{'name': 'Digital Navigation', 'type': 'OTHER', 'description': '1:1 educational support at the bedside about the functions of the patient portal and telehealth that can help with care transitions.', 'armGroupLabels': ['Digital Navigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jorge A Rodriguez, MD', 'role': 'CONTACT'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Jorge A Rodriguez, MD', 'role': 'CONTACT', 'email': 'bwhtelediabetes@partners.org', 'phone': '617-732-7063'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'There is no current plan to share data with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jorge A. Rodriguez, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}