Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-01-01 @ 10:03 PM
Study NCT ID:
NCT04114669
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2019-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP)
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-20', 'size': 1054334, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-15T11:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline, Month 6', 'description': 'Three seated BPs will be measured after a rest period (5 minutes) using an automated device (Omron, Lake Forest, IL) which will reduce the potential for observer bias.'}], 'secondaryOutcomes': [{'measure': 'Antihypertensive Adherence', 'timeFrame': 'Baseline, Month 6', 'description': 'Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform. Adherence is measured as percentage of participants who "adhere" to treatment plan, defined as ≥ 80% of days covered.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Blood Pressure']}, 'descriptionModule': {'briefSummary': 'BETTER-BP (Behavioral Economics Trial To Enhance Regulation of Blood Pressure) is a phase II, single-center, prospective, pragmatic randomized clinical trial within the New York City Health and Hospitals (NYC-H+H) system and NYU Langone Family Health Centers. The trial will recruit from 3 NYC-H+H ambulatory clinics as well as NYU Langone Family Health Centers, and will use a lottery incentive program to promote adherence to antihypertensive medication that will be delivered via smartphone for 6 months. The trial will randomize 435 patients with hypertension determined to have poor adherence (\\<80% adherence with antihypertensive medication), in a 2:1 (intervention:control) ratio. Baseline enrollment will occur over 36 months with an expected 12 months follow-up per participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of hypertension.\n* An active prescription for ≥1 antihypertensive medication (any of the following classes: thiazide diuretic, ACE inhibitor, angiotensin receptor blocker, beta blocker, calcium channel blocker, centrally acting alpha agonist, direct vasodilator).\n\n * 1 ambulatory systolic blood pressure ≥140 mmHg (on therapy).\n* Suboptimal adherence (self-report).\n\nExclusion Criteria:\n\n* Incarcerated\n* Pregnant\n* Unable to use study software (Way To Health) in English or Spanish\n* Unable/unwilling to consent\n* Clear barrier to technology use (e.g. visual or hearing impairment)\n* Projected life expectancy \\<12 months'}, 'identificationModule': {'nctId': 'NCT04114669', 'acronym': 'BETTER-BP', 'briefTitle': 'Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP)', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Behavioral Economics Trial To Enhance Regulation of Blood Pressure', 'orgStudyIdInfo': {'id': '19-00952'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regret lottery', 'description': 'Will receive a lottery incentive ("regret lottery") for 6 months', 'interventionNames': ['Behavioral: Regret Lottery']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Condition', 'description': 'Will complete a total of 3 in-person study visits, approximately one hour each.', 'interventionNames': ['Behavioral: Control Condition']}], 'interventions': [{'name': 'Control Condition', 'type': 'BEHAVIORAL', 'description': '3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.', 'armGroupLabels': ['Control Condition']}, {'name': 'Regret Lottery', 'type': 'BEHAVIORAL', 'description': 'Delivered by the Way to Health platform, installed on a smartphone and communicates with participants via text message.Participants are eligible to receive a potential cash reward if they are adherent with their antihypertensive medication the day before, which is monitored via electronic monitoring device (EMD) from AdhereTech. Each participant is assigned a 2-digit number for the trial, and each day the Way to Health platform randomly generates a 2-digit number. Participants will receive a prize if both digits match (1 in 100 chance) and will receive a prize of lesser value if one digit matches (18 in 100 chance). If they are not adherent with their medication, but would have won if they were adherent, they receive a text message that they would have won ("regret" component).', 'armGroupLabels': ['Regret lottery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'John Dodson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}