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Precision Nudging for Hypertension Management: Observational Study

Data-driven Personalization for Inclusive Outreach and Equitable Outcomes in a Digital Health Intervention for Hypertension Management: A Prospective Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06354192
Enrollment
12000
Registered
2024-04-09
Start date
2024-05-01
Completion date
2026-11-01
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Medication adherence, Self-monitoring of blood pressure, Clinical encounters, Health equity, Precision nudging, Digital health intervention, Behavioral reinforcement learning

Brief 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. 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).

Interventions

BEHAVIORALPrecision Nudging for Hypertension Management

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.

Sponsors

Lirio
Lead SponsorINDUSTRY
Cone Health
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* Non-English speaking. * Globally unsubscribed. * Locally unsubscribed. * Deceased.

Design outcomes

Primary

MeasureTime frameDescription
Clinical encounter behavioral outcome0-18 monthsAdherence with recommended clinical encounters given eligibility based on blood pressure readings and medication
Blood pressure reading clinical outcome0-18 monthsBlood pressure reading

Secondary

MeasureTime frameDescription
Engagement0-18 monthsDigital engagement (opens, clicks, responses, etc.)
Medication adherence behavioral outcome0-18 monthsSelf-reported medication adherence
Self-monitoring of blood pressure behavioral outcome0-18 monthsSelf-reported self-monitoring of blood pressure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026