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

ConditionHypertension

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorNational Bureau of Economic Research, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.)

Disqualifiers

Pregnancy

Under age 18 years

Institutionalized individuals who are likely to be vulnerable

Dependent on supplemental oxygen

Trial design

Design model

Parallel

Treatments tested in this trial

Digital heath tool
Other intervention
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 recommendation
Other intervention
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 recommendation
Other intervention
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.

Treatment groups

3,000 Participants

are divided into 3 treatment groups

Group A: RCT Arm A: Digital health toolExperimental treatment 1 intervention

Group B: RCT Arm B.1: Digital health tool + low-intensity recommendationsExperimental treatment 2 interventions

Group C: RCT Arm B.2: Digital health tool + high-intensity recommendationsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Systolic blood pressure measurement

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Bureau of Economic Research, Inc.

Lead sponsor

National Institute on Aging (NIA)

Collaborator

University of California, San Diego

Collaborator

Source ClinicalTrials.gov

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