Clinical trial NCT06337734: An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Average change in systolic blood pressure (SBP) from baseline to 12 weeks
timeFrame: 12 weeks
measure: Average change in diastolic blood pressure (DBP) from baseline to 12 weeks
timeFrame: 12 weeks
measure: Average change in SBP from baseline to 24 weeks
timeFrame: 24 weeks
measure: Average change in DBP from baseline to 24 weeks
timeFrame: 24 weeks
measure: Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks
timeFrame: 12 weeks
measure: Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks
timeFrame: 24 weeks
measure: Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks
timeFrame: 12 weeks
measure: Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Average weekly percentage of active participants measuring their BP
timeFrame: 24 weeks
measure: Average weekly percentage of active participants syncing their wearable
timeFrame: 24 weeks
measure: Average weekly percentage of active participants answering the mobile app questionnaire
timeFrame: 24 weeks
measure: Number of manual clinician outreaches based on the escalation rules set for the study
timeFrame: 24 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References: