Personalized Blood Pressure Care Using IoMTs and Artificial Intelligence

University of California San Diego

Status: Unknown

Conditions: Pre-hypertension

Treatments: Behavioral: AI-Based Lifestyle Recommendations; Other: No Lifestyle Recommendations

Study type: Interventional

Funder types: Other

Identifiers

NCT04543656

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Details and patient eligibility

About

In this RCT, up to 100 adults classified as pre-hypertensive will be randomized to either an artificial intelligence (AI) based lifestyle intervention group or an active control group with a 1 to 1 ratio. Both groups will receive an identical activity tracker (Samsung Galaxy Watch) and BP monitor (Omron Evolv). The AI intervention group will receive automated and personalized lifestyle recommendations based on their lifestyle (e.g. sleep, exercise and diet) and blood pressure (BP) data, involving an automated analytics engine using statistics and machine learning. The active control group will not receive these lifestyle recommendations. The investigators aim to assess objectively the effectiveness of the AI-based personalized lifestyle recommendations on the patients BP.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age ≥18 years
• SBP between 130 mmHg to 139 mmHg or/and DBP between 80 to 89 mmHg in a research office
• speaking and reading English
• having an iPhone 8 or newer or an Android x or newer

Exclusion criteria

• currently taking antihypertensive medication
• self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes)
• current participation in a lifestyle modification program or research study
• self-report of being currently pregnant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

AI-Based Lifestyle Recommendations Group

Experimental group

Description:

Participants in this group receive AI-based, personalized lifestyle recommendations based on analysis of their activity tracker and blood pressure data.

Treatment:

Behavioral: AI-Based Lifestyle Recommendations

Control Group

Active Comparator group

Description:

Participants in this group do not receive the lifestyle recommendations, but are provided with an identical activity tracker and blood pressure monitor.

Treatment:

Other: No Lifestyle Recommendations