Personalized Blood Pressure Care Using IoMTs and Artificial Intelligence

Not Applicable

• Conditions: Pre-hypertension
• Interventions: Behavioral: AI-Based Lifestyle Recommendations; Other: No Lifestyle Recommendations

• Registration Number: NCT04543656
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-10
• Study Start: 2020-10-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AI-Based Lifestyle Recommendations Group	AI-Based Lifestyle Recommendations	Participants in this group receive AI-based, personalized lifestyle recommendations based on analysis of their activity tracker and blood pressure data.
Control Group	No Lifestyle Recommendations	Participants in this group do not receive the lifestyle recommendations, but are provided with an identical activity tracker and blood pressure monitor.

Primary Outcome Measures

Name	Time	Method
Average change in systolic blood pressure (SBP) in experimental vs. control group	Initial 2 week data collection, weekly lifestyle recommendations, 6 months total	Average SBP during the first and last week of a patient's enrollment will be used to calculate SBP change for each patient.
Average change in diastolic blood pressure (DBP) in experimental vs. control group	Initial 2 week data collection, weekly lifestyle recommendations, 6 months total	Average DBP during the first and last week of a patient's enrollment will be used to calculate DBP change for each patient.

Secondary Outcome Measures

Name	Time	Method
Number of patients in experimental group that followed lifestyle recommendations	Initial 2 week data collection, weekly lifestyle recommendations, 6 months total	This secondary outcome measure is interested in assessing patient engagement within the experimental group. Data from the activity tracker (steps, sleep quality, active minutes, etc.) will be used to assess whether a patient followed the lifestyle recommendations.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States