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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06337734
• Other study ID #: 2
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average change in systolic blood pressure (SBP) from baseline to 12 weeks		12 weeks
Primary	Average change in diastolic blood pressure (DBP) from baseline to 12 weeks		12 weeks
Primary	Average change in SBP from baseline to 24 weeks		24 weeks
Primary	Average change in DBP from baseline to 24 weeks		24 weeks
Primary	Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks		12 weeks
Primary	Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks		24 weeks
Primary	Percent change of participants with Stage 2 Hypertension (SBP=140 or DBP=90) from baseline to 12 weeks		12 weeks
Primary	Percent change of participants with Stage 2 Hypertension (SBP=140 or DBP=90) from baseline to 24 weeks		24 weeks
Secondary	Average weekly percentage of active participants measuring their BP		24 weeks
Secondary	Average weekly percentage of active participants syncing their wearable		24 weeks
Secondary	Average weekly percentage of active participants answering the mobile app questionnaire		24 weeks
Secondary	Number of manual clinician outreaches based on the escalation rules set for the study		24 weeks