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

NCT ID: NCT06337734

Last Updated: 2024-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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AI-Driven Lifestyle Coaching Group

Group Type EXPERIMENTAL

AI-Driven Lifestyle Coaching Program

Intervention Type BEHAVIORAL

The intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Sujit Dey

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Diego

La Jolla, California, United States

Site Status

Countries

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United States

References

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Leitner J, Chiang PH, Agnihotri P, Dey S. The Effect of an AI-Based, Autonomous, Digital Health Intervention Using Precise Lifestyle Guidance on Blood Pressure in Adults With Hypertension: Single-Arm Nonrandomized Trial. JMIR Cardio. 2024 May 28;8:e51916. doi: 10.2196/51916.

Reference Type DERIVED
PMID: 38805253 (View on PubMed)

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id

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