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OpenTrials
Completed

NCT Number: NCT06337734

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-Driven Lifestyle Coaching Program

Behavioral

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

Primary outcomes

  1. Average change in systolic blood pressure (SBP) from baseline to 12 weeks

    Time frame: 12 weeks

  2. Average change in diastolic blood pressure (DBP) from baseline to 12 weeks

    Time frame: 12 weeks

  3. Average change in SBP from baseline to 24 weeks

    Time frame: 24 weeks

  4. Average change in DBP from baseline to 24 weeks

    Time frame: 24 weeks

  5. Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks

    Time frame: 12 weeks

  6. Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks

    Time frame: 24 weeks

  7. Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks

    Time frame: 12 weeks

  8. Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks

    Time frame: 24 weeks

Secondary outcomes

  1. Average weekly percentage of active participants measuring their BP

    Time frame: 24 weeks

  2. Average weekly percentage of active participants syncing their wearable

    Time frame: 24 weeks

  3. Average weekly percentage of active participants answering the mobile app questionnaire

    Time frame: 24 weeks

  4. Number of manual clinician outreaches based on the escalation rules set for the study

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2024
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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