NCT06337734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

1.7 years

First QC Date

March 22, 2024

Last Update Submit

March 28, 2024

Conditions

Hypertension

Outcome Measures

Primary Outcomes (8)

  • 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

  • Average change in SBP from baseline to 24 weeks

    24 weeks

  • Average change in DBP from baseline to 24 weeks

    24 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

Secondary Outcomes (4)

  • 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

Study Arms (1)

AI-Driven Lifestyle Coaching Group

EXPERIMENTAL
Behavioral: AI-Driven Lifestyle Coaching Program

Interventions

AI-Driven Lifestyle Coaching ProgramBEHAVIORAL

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

AI-Driven Lifestyle Coaching Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

  • 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.

    PMID: 38805253DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2024

First Posted

March 29, 2024

Study Start

November 1, 2021

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

April 1, 2024

Record last verified: 2024-03

Locations

US(1)