HypertensionNCT06354192
Precision Nudging for Hypertension Management: Observational Study
An observational study of Hypertension, run by Lirio at 1 site in United States.
Trial summary
The purpose of the proposed observational study is to explore the relations between data-driven personalization and equitable health outcomes in a digital health intervention (DHI) for hypertension management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Precision Nudging for Hypertension Management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: This observational study will follow participants enrolled in a digital health intervention for hypertension management at one of nine Cone Health Community Access Clinics.
Who may be able to join
- Patient of Cone Health.
- Hypertension condition considered "uncontrolled" (signaled by an eligibility indicator).
- Most recent blood pressure reading is at or higher than 160/90 (lowered to 140/90 in April 2025 in accordance with approved protocol)
Who cannot join
- Non-English speaking.
- Globally unsubscribed.
- Locally unsubscribed.
- Deceased.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cone Health clinics
Greensboro, North Carolina, 27401
About this study
Official title: Data-driven Personalization for Inclusive Outreach and Equitable Outcomes in a Digital Health Intervention for Hypertension Management: A Prospective Observational Study
The purpose of the proposed observational study is to explore the relations between data-driven personalization and equitable health outcomes in a digital health intervention (DHI) for hypertension management. In the current intervention, behavioral reinforcement learning is applied to personalize intervention content to maximize the behavioral outcomes of three target behaviors critical for effective hypertension management: clinical encounters, medication adherence, and self-monitoring of blood pressure (SMBP).
- Conditions
- Hypertension
- Being tested
- Precision Nudging for Hypertension Management
- Keywords
- Medication adherence, Self-monitoring of blood pressure, Clinical encounters, Health equity, Precision nudging, Digital health intervention, Behavioral reinforcement learning
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Nudging for Hypertension ManagementBehavioural
Also called Digital Health Intervention, Artificial Intelligence Driven Intervention
The hypertension digital health intervention under study combines behavioral science theory with a type of machine learning called reinforcement learning to enable precision nudging: the selection, assembly, and delivery of behavioral science-based messages created to address barriers to, and promote, management of hypertension. The behavioral design process used for the hypertension DHI intentionally includes research on traditionally underserved populations, such as racial and ethnic minorities and people with lower incomes or educational attainment. By including the right ingredients to meet a diverse set of needs and by effectively personalizing the content each individual sees based on their own reactions, the intervention aims to improve health equity by matching each individual to the right behavioral approach.
| Study group | Role | What they receive |
|---|---|---|
| Precision Nudging for Hypertension Management | All participants in this study will receive the digital health intervention. Receives: Behavioral: Precision Nudging for Hypertension Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical encounter behavioral outcome
Adherence with recommended clinical encounters given eligibility based on blood pressure readings and medication
Measured: 0-18 months
Blood pressure reading clinical outcome
Blood pressure reading
Measured: 0-18 months
Secondary outcomes (3)
Engagement
Digital engagement (opens, clicks, responses, etc.)
Measured: 0-18 months
Medication adherence behavioral outcome
Self-reported medication adherence
Measured: 0-18 months
Self-monitoring of blood pressure behavioral outcome
Self-reported self-monitoring of blood pressure
Measured: 0-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 May 2024
- Primary completion26 Jun 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lirio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cone Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354192
- Sponsor's protocol ID
- 0450
- Status last verified
- Jun 2026
- First submitted
- 3 Apr 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data-driven Personalization for Inclusive Outreach and Equitable Outcomes in a Digital Health Intervention for Hypertension Management: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06354192
- Acronym / sponsor ID
- 0450
- Conditions
- Hypertension
- Keywords
- Medication adherence, Self-monitoring of blood pressure, Clinical encounters, Health equity, Precision nudging, Digital health intervention, Behavioral reinforcement learning
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- LirioIndustry (pharma, biotech, devices)
- Collaborators
- Cone Health
- Study start
- 1 May 2024 (actual)
- Primary completion
- 26 Jun 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 9 Apr 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.
The purpose of the proposed observational study is to explore the relations between data-driven personalization and equitable health outcomes in a digital health intervention (DHI) for hypertension management. In the current intervention, behavioral reinforcement learning is applied to personalize intervention content to maximize the behavioral outcomes of three target behaviors critical for effective hypertension management: clinical encounters, medication adherence, and self-monitoring of blood pressure (SMBP).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Precision Nudging for Hypertension Management | – | Behavioral: Precision Nudging for Hypertension ManagementAll participants in this study will receive the digital health intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational study will follow participants enrolled in a digital health intervention for hypertension management at one of nine Cone Health Community Access Clinics.
Key inclusion criteria (3 listed)
- Patient of Cone Health.
- Hypertension condition considered "uncontrolled" (signaled by an eligibility indicator).
- Most recent blood pressure reading is at or higher than 160/90 (lowered to 140/90 in April 2025 in accordance with approved protocol)
Key exclusion criteria (4 listed)
- Non-English speaking.
- Globally unsubscribed.
- Locally unsubscribed.
- Deceased.
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 |
|---|---|---|
| Precision Nudging for Hypertension ManagementAlso: Digital Health Intervention, Artificial Intelligence Driven InterventionThe hypertension digital health intervention under study combines behavioral science theory with a type of machine learning called reinforcement learning to enable precision nudging: the selection, assembly, and delivery of behavioral science-based messages created to address barriers to, and promote, management of hypertension. The behavioral design process used for the hypertension DHI intentionally includes research on traditionally underserved populations, such as racial and ethnic minorities and people with lower incomes or educational attainment. By including the right ingredients to meet a diverse set of needs and by effectively personalizing the content each individual sees based on their own reactions, the intervention aims to improve health equity by matching each individual to the right behavioral approach. | Behavioural | Precision Nudging for Hypertension Management |
Primary outcome
Clinical encounter behavioral outcome
Time frame: 0-18 months
Adherence with recommended clinical encounters given eligibility based on blood pressure readings and medication
Blood pressure reading clinical outcome
Time frame: 0-18 months
Blood pressure reading
3 secondary outcomes
Engagement
Time frame: 0-18 months
Medication adherence behavioral outcome
Time frame: 0-18 months
Self-monitoring of blood pressure behavioral outcome
Time frame: 0-18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No. IPD will not be shared.
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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?
An observational study of Hypertension, run by Lirio 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 3 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical encounter behavioral outcome (time frame: 0-18 months). 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 26 Jun 2026.