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Personalized Blood Pressure Care Using IoMTs and Artificial Intelligence

Sponsor
University of California, San Diego (Other)
Overall Status
Recruiting
CT.gov ID
NCT04543656
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this RCT, up to 100 adults classified as pre-hypertensive will be randomized to either an artificial intelligence (AI) based lifestyle intervention group or an active control group with a 1 to 1 ratio. Both groups will receive an identical activity tracker (Samsung Galaxy Watch) and BP monitor (Omron Evolv). The AI intervention group will receive automated and personalized lifestyle recommendations based on their lifestyle (e.g. sleep, exercise and diet) and blood pressure (BP) data, involving an automated analytics engine using statistics and machine learning. The active control group will not receive these lifestyle recommendations. The investigators aim to assess objectively the effectiveness of the AI-based personalized lifestyle recommendations on the patients BP.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: AI-Based Lifestyle Recommendations
  • Other: No Lifestyle Recommendations
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Personalized Blood Pressure Care for Prehypertensive Patients Using IoMTs and Artificial Intelligence
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: AI-Based Lifestyle Recommendations Group

Participants in this group receive AI-based, personalized lifestyle recommendations based on analysis of their activity tracker and blood pressure data.

Behavioral: AI-Based Lifestyle Recommendations
The intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning.
Active Comparator: Control Group

Participants in this group do not receive the lifestyle recommendations, but are provided with an identical activity tracker and blood pressure monitor.

Other: No Lifestyle Recommendations
The control group receives an identical activity tracker and BP monitor in order to objectively assess the effectiveness of the experimental group intervention.

Outcome Measures

Primary Outcome Measures

  1. Average change in systolic blood pressure (SBP) in experimental vs. control group [Initial 2 week data collection, weekly lifestyle recommendations, 6 months total]

    Average SBP during the first and last week of a patient's enrollment will be used to calculate SBP change for each patient.

  2. Average change in diastolic blood pressure (DBP) in experimental vs. control group [Initial 2 week data collection, weekly lifestyle recommendations, 6 months total]

    Average DBP during the first and last week of a patient's enrollment will be used to calculate DBP change for each patient.

Secondary Outcome Measures

  1. Number of patients in experimental group that followed lifestyle recommendations [Initial 2 week data collection, weekly lifestyle recommendations, 6 months total]

    This secondary outcome measure is interested in assessing patient engagement within the experimental group. Data from the activity tracker (steps, sleep quality, active minutes, etc.) will be used to assess whether a patient followed the lifestyle recommendations.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • age ≥18 years

  • SBP between 130 mmHg to 139 mmHg or/and DBP between 80 to 89 mmHg in a research office

  • speaking and reading English

  • having an iPhone 8 or newer or an Android x or newer

Exclusion Criteria:

  • currently taking antihypertensive medication

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Diego La Jolla California United States 92093

Sponsors and Collaborators

  • University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sujit Dey, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT04543656
Other Study ID Numbers:
  • 1
First Posted:
Sep 10, 2020
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prehypertension

Study Results

No Results Posted as of Sep 28, 2021