Personalized Blood Pressure Care Using IoMTs and Artificial Intelligence
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|ClinicalTrials.gov Identifier: NCT04543656|
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : September 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pre-hypertension||Behavioral: AI-Based Lifestyle Recommendations Other: No Lifestyle Recommendations||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Personalized Blood Pressure Care for Prehypertensive Patients Using IoMTs and Artificial Intelligence|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
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.
- Average change in systolic blood pressure (SBP) in experimental vs. control group [ Time Frame: 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.
- Average change in diastolic blood pressure (DBP) in experimental vs. control group [ Time Frame: 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.
- Number of patients in experimental group that followed lifestyle recommendations [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543656
|Contact: Sujit Dey, PhDemail@example.com|
|United States, California|
|University of California, San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Sujit Dey|