Personalized Blood Pressure Care Using IoMTs and Artificial Intelligence

Personalized Blood Pressure Care for Prehypertensive Patients Using IoMTs and Artificial Intelligence

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.

Study Overview

• Status: Recruiting
• Conditions: Pre-hypertension
• Intervention / Treatment: Behavioral: AI-Based Lifestyle Recommendations; Other: No Lifestyle Recommendations

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sujit Dey, PhD; Phone Number: 8587617518; Email: dey@eng.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California, San Diego
      • Contact: Sujit Dey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AI-Based Lifestyle Recommendations Group; Participants in this group receive AI-based, personalized lifestyle recommendations based on analysis of their activity tracker and blood pressure data.	Behavioral: AI-Based Lifestyle Recommendations; The intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning.
ACTIVE_COMPARATOR: Control Group; Participants in this group do not receive the lifestyle recommendations, but are provided with an identical activity tracker and blood pressure monitor.	Other: No Lifestyle Recommendations; The control group receives an identical activity tracker and BP monitor in order to objectively assess the effectiveness of the experimental group intervention.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients in experimental group that followed lifestyle recommendations	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.	Initial 2 week data collection, weekly lifestyle recommendations, 6 months total

Collaborators and Investigators

• Sponsor: University of California, San Diego

Publications and helpful links

Helpful Links

• Offline and Online Learning Techniques for Personalized Blood Pressure Prediction and Health Behavior Recommendations

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (ACTUAL): September 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Prehypertension
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No