HypertensionNCT06337734
An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension
A study testing AI-Driven Lifestyle Coaching Program in people with Hypertension, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- AI-Driven Lifestyle Coaching Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 1 Aug 2023
- 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
- 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
Who cannot join
- 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
University of California, San Diego
La Jolla, California, 92093
About this study
Official 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
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.
- Conditions
- Hypertension
- Being tested
- AI-Driven Lifestyle Coaching Program
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Driven Lifestyle Coaching ProgramBehavioural
The intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning.
| Study group | Role | What they receive |
|---|---|---|
| AI-Driven Lifestyle Coaching Group | Experimental | Not described Receives: Behavioral: AI-Driven Lifestyle Coaching Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in systolic blood pressure (SBP) from baseline to 12 weeks
Measured: 12 weeks
Average change in diastolic blood pressure (DBP) from baseline to 12 weeks
Measured: 12 weeks
Average change in SBP from baseline to 24 weeks
Measured: 24 weeks
Average change in DBP from baseline to 24 weeks
Measured: 24 weeks
Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks
Measured: 12 weeks
Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks
Measured: 24 weeks
Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks
Measured: 12 weeks
Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks
Measured: 24 weeks
Secondary outcomes (4)
Average weekly percentage of active participants measuring their BP
Measured: 24 weeks
Average weekly percentage of active participants syncing their wearable
Measured: 24 weeks
Average weekly percentage of active participants answering the mobile app questionnaire
Measured: 24 weeks
Number of manual clinician outreaches based on the escalation rules set for the study
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Nov 2021
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
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
- NCT06337734
- Sponsor's protocol ID
- 2
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38805253
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06337734
- Acronym / sponsor ID
- 2
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 29 Mar 2024 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI-Driven Lifestyle Coaching Group | Experimental | Behavioral: AI-Driven Lifestyle Coaching Program |
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
- 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
Key exclusion criteria (3 listed)
- 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-Driven Lifestyle Coaching ProgramThe intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning. | Behavioural | AI-Driven Lifestyle Coaching Group |
Primary outcome
Average change in systolic blood pressure (SBP) from baseline to 12 weeks
Time frame: 12 weeks
Average change in diastolic blood pressure (DBP) from baseline to 12 weeks
Time frame: 12 weeks
Average change in SBP from baseline to 24 weeks
Time frame: 24 weeks
Average change in DBP from baseline to 24 weeks
Time frame: 24 weeks
Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks
Time frame: 12 weeks
Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks
Time frame: 24 weeks
Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks
Time frame: 12 weeks
Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks
Time frame: 24 weeks
4 secondary outcomes
Average weekly percentage of active participants measuring their BP
Time frame: 24 weeks
Average weekly percentage of active participants syncing their wearable
Time frame: 24 weeks
Average weekly percentage of active participants answering the mobile app questionnaire
Time frame: 24 weeks
Number of manual clinician outreaches based on the escalation rules set for the study
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Derived from this study: PubMed 38805253Leitner 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-Driven Lifestyle Coaching Program in people with 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 3 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: finished, as of the sponsor's last update on 1 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average change in systolic blood pressure (SBP) from baseline to 12 weeks (time frame: 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06337734, which also lists 1 linked publication.
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 1 Apr 2024.