An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension

The Effect of an Artificial Intelligence-based, Autonomous, Digital Health Intervention Using Precise Lifestyle Guidance on Blood Pressure in Adults With Hypertension: Single-Arm Nonrandomized Trial

This study evaluates the impact of a fully digital, autonomous, and artificial intelligence (AI)-driven lifestyle coaching program on managing blood pressure (BP) among adults diagnosed with hypertension. Participants received a BP monitor and a wearable activity tracker to facilitate data collection. This data, along with responses from a questionnaire mobile app, were analyzed by an automated analytics engine employing statistical and machine learning techniques. The program delivered tailored lifestyle coaching directly to participants through a mobile app, aiming for precise and effective BP management.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: AI-Driven Lifestyle Coaching Program

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ≥18 years
• Stage 2 hypertension based on their most recent clinical measurement (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg per the 2017 American College of Cardiology/American Heart Association guidelines)
• Speaking and reading English
• Having an Apple iPhone 6s or later, or an Android phone running Android 8.0 or later

Exclusion Criteria:

• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-Driven Lifestyle Coaching Group	Behavioral: AI-Driven Lifestyle Coaching Program; The intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average change in systolic blood pressure (SBP) from baseline to 12 weeks	12 weeks
Average change in diastolic blood pressure (DBP) from baseline to 12 weeks	12 weeks
Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks	12 weeks
Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks	24 weeks
Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks	12 weeks
Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks	24 weeks
Average change in SBP from baseline to 24 weeks	24 weeks
Average change in DBP from baseline to 24 weeks	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Average weekly percentage of active participants measuring their BP	24 weeks
Average weekly percentage of active participants syncing their wearable	24 weeks
Average weekly percentage of active participants answering the mobile app questionnaire	24 weeks
Number of manual clinician outreaches based on the escalation rules set for the study	24 weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Drug and device information, study documents

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