Behavioral Interventions Combining AI/ML and Personalized Medicine to Reduce Cardiovascular Risk - Randomized Controlled Trial
2 other identifiers
interventional
3,000
1 country
1
Brief Summary
This study evaluates a new digital health program that uses artificial intelligence (AI) to help patients lower their blood pressure through personalized lifestyle recommendations. The program collects information about patients' daily habits and blood pressure readings, then uses AI to suggest lifestyle changes that may work best for each person. The study will measure how well this program works across different groups of patients and aims to improve the program design to make it more effective and easier to use. The program will be offered to diverse patients at UC San Diego Health, including people of different ages, genders, races/ethnicities, and economic backgrounds, as part of their regular healthcare services.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2026
CompletedFirst Submitted
Initial submission to the registry
July 21, 2026
CompletedFirst Posted
Study publicly available on registry
July 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
July 24, 2026
July 1, 2026
1.1 years
July 21, 2026
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systolic blood pressure measurement
6 months
Study Arms (3)
RCT Arm A: Digital health tool
EXPERIMENTALParticipants in this arm will receive the Digital Health Tool intervention.
RCT Arm B.1: Digital health tool + low-intensity recommendations
EXPERIMENTALParticipants in this arm will receive the Digital Health Tool and Low-Intensity Recommendation interventions.
RCT Arm B.2: Digital health tool + high-intensity recommendations
EXPERIMENTALParticipants in this arm will receive the Digital Health Tool and High-Intensity Recommendation interventions.
Interventions
Digital health tool of patient-tailored lifestyle recommendations for blood pressure maintenance. Current "simplified" remote patient monitoring program referred to as "P1000." Requires daily blood pressure readings only.
AI-enhanced lifestyle and health recommendations provided weekly. This requires blood pressure readings, as well as passive readings, (e.g. sleep, movement), and a daily questionnaire.
AI-enhanced lifestyle and health recommendations provided weekly, plus daily reminders. This requires blood pressure readings, as well as passive readings, (e.g. sleep, movement), and a daily questionnaire.
Eligibility Criteria
You may qualify if:
- Stage I-II hypertension (average clinical readings of blood pressure over 140/90)
- Adequate decisional capacity to make a choice about participating in this research study
- Fully ambulatory (not requiring assistive device such as a cane, wheelchair, walker, etc.)
You may not qualify if:
- Pregnancy
- Under age 18 years
- Institutionalized individuals who are likely to be vulnerable
- Dependent on supplemental oxygen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Bureau of Economic Research, Inc.lead
- National Institute on Aging (NIA)collaborator
- University of California, San Diegocollaborator
Study Sites (1)
University of California, San Diego
La Jolla, California, 92093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Itzik Fadlon
National Bureau of Economic Research, Inc.
- PRINCIPAL INVESTIGATOR
Ming Tai-Seale
University of California, San Diego
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2026
First Posted
July 24, 2026
Study Start
April 10, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
July 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- We plan to publicly archive our statistical analysis plan (SAP) and study protocol at ClinicialTrials.gov before performing any data analysis. This will serve both as an ex ante record of the hypotheses to be tested and provide a resource to other researchers interested in implementing similar study designs. We plan to share the individual participant data (IPD), analytic code, and supporting materials in multiple ways. The resources will be posted to ClinicalTrials.gov by the paper's online publication date or within 12 months of the primary completion date (whichever comes first), in accordance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149). We will also catalog public use data and analytic code on the NBER Data Archive (www.nber.org/data/) to encourage its use by the wider community. We expect to receive institutional approval at the appropriate times for all resource sharing.
All study data, except for identifiers, will be shared. Before data is shared publicly, all identifiers will be removed in keeping with HIPAA standards (i.e., §164.514(b)1 or (b)2) and the standards of the IRB of Record. Identifiable data will not be shared publicly and will be stored only on secure servers and accessed only by personnel with appropriate training and a legitimate need to know.