Pre-hypertensionNCT04543656
Personalized Blood Pressure Care Using IoMTs and Artificial Intelligence
A study testing AI-Based Lifestyle Recommendations and No Lifestyle Recommendations in people with Pre-hypertension, run by University of California, San Diego at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-hypertension
- What is being tested?
- AI-Based Lifestyle Recommendations and No Lifestyle Recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92093
Sujit Dey
About this study
Official title: Personalized Blood Pressure Care for Prehypertensive Patients Using IoMTs and Artificial Intelligence
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.
- Conditions
- Pre-hypertension
- Being tested
- AI-Based Lifestyle Recommendations, No Lifestyle Recommendations
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Based Lifestyle RecommendationsBehavioural
The intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning.
No Lifestyle RecommendationsOther
The control group receives an identical activity tracker and BP monitor in order to objectively assess the effectiveness of the experimental group intervention.
| Study group | Role | What they receive |
|---|---|---|
| AI-Based Lifestyle Recommendations Group | Experimental | Participants in this group receive AI-based, personalized lifestyle recommendations based on analysis of their activity tracker and blood pressure data. Receives: Behavioral: AI-Based Lifestyle Recommendations |
| Control Group | Active comparator | Participants in this group do not receive the lifestyle recommendations, but are provided with an identical activity tracker and blood pressure monitor. Receives: Other: No Lifestyle Recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in systolic blood pressure (SBP) in experimental vs. control group
Average SBP during the first and last week of a patient's enrollment will be used to calculate SBP change for each patient.
Measured: Initial 2 week data collection, weekly lifestyle recommendations, 6 months total
Average change in diastolic blood pressure (DBP) in experimental vs. control group
Average DBP during the first and last week of a patient's enrollment will be used to calculate DBP change for each patient.
Measured: Initial 2 week data collection, weekly lifestyle recommendations, 6 months total
Secondary outcomes (1)
Number of patients in experimental group that followed lifestyle recommendations
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.
Measured: Initial 2 week data collection, weekly lifestyle recommendations, 6 months total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Oct 2020
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-hypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sujit Dey, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543656
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2021
- First submitted
- 10 Aug 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Blood Pressure Care for Prehypertensive Patients Using IoMTs and Artificial Intelligence
- ClinicalTrials.gov ID
- NCT04543656
- Acronym / sponsor ID
- 1
- Conditions
- Pre-hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Based Lifestyle Recommendations Group | Experimental | Behavioral: AI-Based Lifestyle RecommendationsParticipants in this group receive AI-based, personalized lifestyle recommendations based on analysis of their activity tracker and blood pressure data. |
| Control Group | Active comparator | Other: No Lifestyle RecommendationsParticipants in this group do not receive the lifestyle recommendations, but are provided with an identical activity tracker and blood pressure monitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Based Lifestyle RecommendationsThe intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning. | Behavioural | AI-Based Lifestyle Recommendations Group |
| No Lifestyle RecommendationsThe control group receives an identical activity tracker and BP monitor in order to objectively assess the effectiveness of the experimental group intervention. | Other | Control Group |
Primary outcome
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.
1 secondary outcome
Number of patients in experimental group that followed lifestyle recommendations
Time frame: Initial 2 week data collection, weekly lifestyle recommendations, 6 months total
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Offline and Online Learning Techniques for Personalized Blood Pressure Prediction and Health Behavior RecommendationsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Based Lifestyle Recommendations and No Lifestyle Recommendations in people with Pre-hypertension, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sujit Dey, PhD (8587617518, dey@eng.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.