Behavioral Interventions Combining AI/ML and Personalized Medicine to Reduce Cardiovascular Risk - Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital heath tool, Low-intensity recommendation, High-intensity recommendation.
- Who it may be relevant to
- Registry conditions: Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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. - 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.
Primary outcome measures
- Systolic blood pressure measurement [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, San Diego — La Jolla
Identifiers
NCT: NCT07725250 · 8577_RCT · 5P30AG034532