Behavioral Interventions Combining AI/ML and Personalized Medicine to Reduce Cardiovascular Risk - Randomized Controlled Trial

July 21, 2026 updated by: National Bureau of Economic Research, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.)

Exclusion Criteria:

  • Pregnancy
  • Under age 18 years
  • Institutionalized individuals who are likely to be vulnerable
  • Dependent on supplemental oxygen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RCT Arm A: Digital health tool
Participants in this arm will receive the Digital Health Tool intervention.
Other: Digital heath tool
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.
Experimental: RCT Arm B.1: Digital health tool + low-intensity recommendations
Participants in this arm will receive the Digital Health Tool and Low-Intensity Recommendation interventions.
Other: Digital heath tool
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.
Other: Low-intensity recommendation
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.
Experimental: RCT Arm B.2: Digital health tool + high-intensity recommendations
Participants in this arm will receive the Digital Health Tool and High-Intensity Recommendation interventions.
Other: Digital heath tool
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.
Other: High-intensity recommendation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systolic blood pressure measurement
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Bureau of Economic Research, Inc.

Collaborators

University of California, San Diego
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Itzik Fadlon, National Bureau of Economic Research, Inc.
  • Principal Investigator: Ming Tai-Seale, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 21, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8577_RCT
  • 5P30AG034532 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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