Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-25 @ 2:25 PM
Study NCT ID:
NCT07174466
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The e-SINCERE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'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': 'NONE', 'maskingDescription': "Services to which participants are referred will not be aware of the participant's inclusion in the research study or their study arm."}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful connection to community social services (any service)', 'timeFrame': '6 months after randomization', 'description': 'Proportion of participants who have at least one documented successful connection to a community social service (e.g., housing assistance, utilities, food support, transportation) within 6 months. Successful connection is defined as a recorded positive outcome in 211 or ServicePoint (client reached and service initiated) or participant self-report confirmed by case notes.'}], 'secondaryOutcomes': [{'measure': 'Health-related quality of life (PROMIS Global Health)', 'timeFrame': 'Baseline, 2 weeks, 3 months, and 6 months after randomization', 'description': 'Change in PROMIS Global Health T-score from baseline to 6 months. Higher scores indicate better overall physical and mental health. Analysis will compare mean change between arms.'}, {'measure': 'Emergency department utilization (all-cause ED visits)', 'timeFrame': '6 months after randomization', 'description': "Number of all-cause ED visits per participant during the 6-month follow-up period, obtained from the institution's EDW and participant self-report for non-UHealth visits. Analysis will compare mean visits and proportion with any ED revisit between arms."}, {'measure': 'Digital access stability (phone connectivity)', 'timeFrame': '6 months after randomization', 'description': 'Proportion of participants in the phone/navigation arms with continuous phone connectivity (TracFone active and reachable) for at least 5 of 6 months. Connectivity assessed via phone service logs and navigator contact attempts.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Social Determinants of Health (SDOH)', 'Digital Health Literacy', 'Health Services Utilization']}, 'descriptionModule': {'briefSummary': 'The e-SINCERE study will evaluate whether providing stable cell phones and digital navigation assistance helps patients overcome ICT barriers and connect more successfully with community services. The study will begin with patients in the UHealth ED, with additional sites added in the future, and will involve working with community service providers and policy leaders to refine and implement the intervention. Findings from this study may guide the development of future programs and policies to improve access to services for patients facing economic and technological barriers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community Advisory Board Members\n\nHealth system, governmental, and community service stakeholders\n\nAble to understand English\n\nAdult (\\> 18 years)\n\n\\- General screening population:\n\nAny patient who completes the SINCERE screener.\n\nAble to understand or read English or Spanish.\n\n\\- Survey study inclusion criteria:\n\nAny patient who completes the SINCERE screener who has connected with 211 for service outreach\n\nAble to understand or read English or Spanish.\n\nAdult (\\> 18 years)\n\nExclusion Criteria:\n\n* Those unable to communicate verbally in English or Spanish\n* Those living in nursing facilities, or those who are not otherwise responsible for self-care'}, 'identificationModule': {'nctId': 'NCT07174466', 'acronym': 'e-SINCERE', 'briefTitle': 'The e-SINCERE Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Enhanced Digital Access to Bridge Social Needs and Reduce Health Disparities: The e-SINCERE Study', 'orgStudyIdInfo': {'id': '00181891'}, 'secondaryIdInfos': [{'id': '1R01NR021501-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01NR021501-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1: Control - Standard Referral to 211', 'description': 'Participants receive usual care plus a referral to United Way 211 for assistance with social needs. No additional study-provided phone or navigation support is given.', 'interventionNames': ['Other: Standard Referral to 211']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Phone - Bridge Phone to 211', 'description': 'Participants receive a study-provided cellphone to ensure stable phone access. They are connected by phone to United Way 211 for assistance with social needs.', 'interventionNames': ['Behavioral: e-SINCERE (Phone Support)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: Navigation - Digital Navigator + 211', 'description': 'Participants receive a study-provided cellphone and direct support from a Digital Navigator. The Navigator assists participants in accessing United Way 211 and helps troubleshoot barriers to connecting with services.', 'interventionNames': ['Behavioral: e-SINCERE (Digital Navigation)']}], 'interventions': [{'name': 'Standard Referral to 211', 'type': 'OTHER', 'description': 'Participants receive a standard referral to United Way 211 for assistance with social needs. 211 specialists contact referred patients, provide available service referrals, and follow up in an ad-hoc manner as per standard 211 protocols.', 'armGroupLabels': ['Arm 1: Control - Standard Referral to 211']}, {'name': 'e-SINCERE (Phone Support)', 'type': 'BEHAVIORAL', 'description': 'Participants receive a study-provided cellphone to ensure stable phone access. Using this device, participants are connected to United Way 211 specialists, who provide referral services for identified social needs. This intervention focuses on overcoming communication barriers that might otherwise prevent successful service connection.', 'armGroupLabels': ['Arm 2: Phone - Bridge Phone to 211']}, {'name': 'e-SINCERE (Digital Navigation)', 'type': 'BEHAVIORAL', 'description': 'Participants receive a study-provided TracFone and direct support from a trained Digital Navigator. The Digital Navigator assists participants with accessing United Way 211 services, troubleshooting barriers to phone or internet use, and reinforcing follow-through on referrals. This arm is designed to provide enhanced, structured navigation support to address digital access barriers and increase successful service connections.', 'armGroupLabels': ['Arm 3: Navigation - Digital Navigator + 211']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Ernest Grigorian, MS', 'role': 'CONTACT', 'email': 'Ernest.Grigorian@utah.edu', 'phone': '801-585-7194'}], 'overallOfficials': [{'name': 'Andrea Wallace, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrea Wallace', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Andrea Wallace', 'investigatorAffiliation': 'University of Utah'}}}}