Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 8:26 AM
Study NCT ID:
NCT06354192
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2024-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Nudging for Hypertension Management: Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical encounter behavioral outcome', 'timeFrame': '0-18 months', 'description': 'Adherence with recommended clinical encounters given eligibility based on blood pressure readings and medication'}, {'measure': 'Blood pressure reading clinical outcome', 'timeFrame': '0-18 months', 'description': 'Blood pressure reading'}], 'secondaryOutcomes': [{'measure': 'Engagement', 'timeFrame': '0-18 months', 'description': 'Digital engagement (opens, clicks, responses, etc.)'}, {'measure': 'Medication adherence behavioral outcome', 'timeFrame': '0-18 months', 'description': 'Self-reported medication adherence'}, {'measure': 'Self-monitoring of blood pressure behavioral outcome', 'timeFrame': '0-18 months', 'description': 'Self-reported self-monitoring of blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medication adherence', 'Self-monitoring of blood pressure', 'Clinical encounters', 'Health equity', 'Precision nudging', 'Digital health intervention', 'Behavioral reinforcement learning'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of the proposed observational study is to explore the relations between data-driven personalization and equitable health outcomes in a digital health intervention (DHI) for hypertension management. In the current intervention, behavioral reinforcement learning is applied to personalize intervention content to maximize the behavioral outcomes of three target behaviors critical for effective hypertension management: clinical encounters, medication adherence, and self-monitoring of blood pressure (SMBP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This observational study will follow participants enrolled in a digital health intervention for hypertension management at one of nine Cone Health Community Access Clinics.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient of Cone Health.\n* Hypertension condition considered "uncontrolled" (signaled by an eligibility indicator).\n* Most recent blood pressure reading is at or higher than 160/90 (lowered to 140/90 in April 2025 in accordance with approved protocol)\n\nExclusion Criteria:\n\n* Non-English speaking.\n* Globally unsubscribed.\n* Locally unsubscribed.\n* Deceased.'}, 'identificationModule': {'nctId': 'NCT06354192', 'briefTitle': 'Precision Nudging for Hypertension Management: Observational Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lirio'}, 'officialTitle': 'Data-driven Personalization for Inclusive Outreach and Equitable Outcomes in a Digital Health Intervention for Hypertension Management: A Prospective Observational Study', 'orgStudyIdInfo': {'id': '0450'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Precision Nudging for Hypertension Management', 'description': 'All participants in this study will receive the digital health intervention.', 'interventionNames': ['Behavioral: Precision Nudging for Hypertension Management']}], 'interventions': [{'name': 'Precision Nudging for Hypertension Management', 'type': 'BEHAVIORAL', 'otherNames': ['Digital Health Intervention', 'Artificial Intelligence Driven Intervention'], 'description': 'The hypertension digital health intervention under study combines behavioral science theory with a type of machine learning called reinforcement learning to enable precision nudging: the selection, assembly, and delivery of behavioral science-based messages created to address barriers to, and promote, management of hypertension. The behavioral design process used for the hypertension DHI intentionally includes research on traditionally underserved populations, such as racial and ethnic minorities and people with lower incomes or educational attainment. By including the right ingredients to meet a diverse set of needs and by effectively personalizing the content each individual sees based on their own reactions, the intervention aims to improve health equity by matching each individual to the right behavioral approach.', 'armGroupLabels': ['Precision Nudging for Hypertension Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Bucher, PhD', 'role': 'CONTACT', 'email': 'abucher@lirio.com', 'phone': '865.243.8000'}, {'name': 'Sarah Deedat, PhD', 'role': 'CONTACT', 'email': 'sdeedat@lirio.com', 'phone': '865.243.8000'}], 'facility': 'Cone Health clinics', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}], 'centralContacts': [{'name': 'Amy Bucher, PhD', 'role': 'CONTACT', 'email': 'abucher@lirio.com', 'phone': '865-839-6158'}, {'name': 'Sarah Deedat, PhD', 'role': 'CONTACT', 'email': 'sdeedat@lirio.com', 'phone': '865-243-8000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lirio', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cone Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}