HypertensionNCT07725250
Behavioral Interventions Combining AI/ML and Personalized Medicine to Reduce Cardiovascular Risk - Randomized Controlled Trial
A study testing Digital heath tool, Low-intensity recommendation and High-intensity recommendation in people with Hypertension, run by National Bureau of Economic Research, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Digital heath tool, Low-intensity recommendation and High-intensity recommendation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- Pregnancy
- Under age 18 years
- Institutionalized individuals who are likely to be vulnerable
- Dependent on supplemental oxygen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ross Graham contact
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92093
Amanda Walker, 617-588-1445, Alw038@health.ucsd.edu
Ross Graham, rograham@health.ucsd.edu
About this study
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.
- Conditions
- Hypertension
- Being tested
- Digital heath tool, Low-intensity recommendation, High-intensity recommendation
- Keywords
- lifestyle recommendations, AI/ML, personalized medicine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital heath toolOther
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.
Low-intensity recommendationOther
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.
High-intensity recommendationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| RCT Arm A: Digital health tool | Experimental | Participants in this arm will receive the Digital Health Tool intervention. Receives: Other: Digital heath tool |
| RCT Arm B.1: Digital health tool + low-intensity recommendations | Experimental | Participants in this arm will receive the Digital Health Tool and Low-Intensity Recommendation interventions. Receives: Other: Digital heath tool; Other: Low-intensity recommendation |
| RCT Arm B.2: Digital health tool + high-intensity recommendations | Experimental | Participants in this arm will receive the Digital Health Tool and High-Intensity Recommendation interventions. Receives: Other: Digital heath tool; Other: High-intensity recommendation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure measurement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start10 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Bureau of Economic Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Itzik Fadlon, Principal investigator, National Bureau of Economic Research, Inc.Ming Tai-Seale, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725250
- Sponsor's protocol ID
- 8577_RCT
- Other IDs
- 5P30AG034532
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Interventions Combining AI/ML and Personalized Medicine to Reduce Cardiovascular Risk - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07725250
- Acronym / sponsor ID
- 8577_RCT
- Conditions
- Hypertension
- Keywords
- lifestyle recommendations, AI/ML, personalized medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Bureau of Economic Research, Inc.University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of California, San Diego
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RCT Arm A: Digital health tool | Experimental | Other: Digital heath toolParticipants in this arm will receive the Digital Health Tool intervention. |
| RCT Arm B.1: Digital health tool + low-intensity recommendations | Experimental | Other: Digital heath tool, Other: Low-intensity recommendationParticipants in this arm will receive the Digital Health Tool and Low-Intensity Recommendation interventions. |
| RCT Arm B.2: Digital health tool + high-intensity recommendations | Experimental | Other: Digital heath tool, Other: High-intensity recommendationParticipants in this arm will receive the Digital Health Tool and High-Intensity Recommendation interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (4 listed)
- Pregnancy
- Under age 18 years
- Institutionalized individuals who are likely to be vulnerable
- Dependent on supplemental oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital heath toolDigital 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 | RCT Arm A: Digital health tool, RCT Arm B.1: Digital health tool + low-intensity recommendations, RCT Arm B.2: Digital health tool + high-intensity recommendations |
| Low-intensity recommendationAI-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. | Other | RCT Arm B.1: Digital health tool + low-intensity recommendations |
| High-intensity recommendationAI-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. | Other | RCT Arm B.2: Digital health tool + high-intensity recommendations |
Primary outcome
Systolic blood pressure measurement
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ross Graham contact
Itzik Fadlon principal investigator
National Bureau of Economic Research, Inc.
Ming Tai-Seale principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital heath tool, Low-intensity recommendation and High-intensity recommendation in people with Hypertension, run by National Bureau of Economic Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Walker (617-588-1445, Alw038@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure measurement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.