Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 8:48 PM
Study NCT ID:
NCT06337734
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2024-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average change in systolic blood pressure (SBP) from baseline to 12 weeks', 'timeFrame': '12 weeks'}, {'measure': 'Average change in diastolic blood pressure (DBP) from baseline to 12 weeks', 'timeFrame': '12 weeks'}, {'measure': 'Average change in SBP from baseline to 24 weeks', 'timeFrame': '24 weeks'}, {'measure': 'Average change in DBP from baseline to 24 weeks', 'timeFrame': '24 weeks'}, {'measure': 'Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks', 'timeFrame': '12 weeks'}, {'measure': 'Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks', 'timeFrame': '24 weeks'}, {'measure': 'Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks', 'timeFrame': '12 weeks'}, {'measure': 'Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Average weekly percentage of active participants measuring their BP', 'timeFrame': '24 weeks'}, {'measure': 'Average weekly percentage of active participants syncing their wearable', 'timeFrame': '24 weeks'}, {'measure': 'Average weekly percentage of active participants answering the mobile app questionnaire', 'timeFrame': '24 weeks'}, {'measure': 'Number of manual clinician outreaches based on the escalation rules set for the study', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '38805253', 'type': 'DERIVED', 'citation': 'Leitner J, Chiang PH, Agnihotri P, Dey S. The Effect of an AI-Based, Autonomous, Digital Health Intervention Using Precise Lifestyle Guidance on Blood Pressure in Adults With Hypertension: Single-Arm Nonrandomized Trial. JMIR Cardio. 2024 May 28;8:e51916. doi: 10.2196/51916.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of a fully digital, autonomous, and artificial intelligence (AI)-driven lifestyle coaching program on managing blood pressure (BP) among adults diagnosed with hypertension. Participants received a BP monitor and a wearable activity tracker to facilitate data collection. This data, along with responses from a questionnaire mobile app, were analyzed by an automated analytics engine employing statistical and machine learning techniques. The program delivered tailored lifestyle coaching directly to participants through a mobile app, aiming for precise and effective BP management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Stage 2 hypertension based on their most recent clinical measurement (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg per the 2017 American College of Cardiology/American Heart Association guidelines)\n* Speaking and reading English\n* Having an Apple iPhone 6s or later, or an Android phone running Android 8.0 or later\n\nExclusion Criteria:\n\n* Self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes)\n* Current participation in a lifestyle modification program or research study\n* Self-report of being currently pregnant'}, 'identificationModule': {'nctId': 'NCT06337734', 'briefTitle': 'An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'The Effect of an Artificial Intelligence-based, Autonomous, Digital Health Intervention Using Precise Lifestyle Guidance on Blood Pressure in Adults With Hypertension: Single-Arm Nonrandomized Trial', 'orgStudyIdInfo': {'id': '2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI-Driven Lifestyle Coaching Group', 'interventionNames': ['Behavioral: AI-Driven Lifestyle Coaching Program']}], 'interventions': [{'name': 'AI-Driven Lifestyle Coaching Program', 'type': 'BEHAVIORAL', 'description': 'The intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning.', 'armGroupLabels': ['AI-Driven Lifestyle Coaching Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sujit Dey', 'investigatorAffiliation': 'University of California, San Diego'}}}}