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

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 Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Precision Nudging for Hypertension Management

• Study Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

• Study Contact: Name: Sarah Deedat, PhD; Phone Number: 865-243-8000; Email: sdeedat@lirio.com
• Study Contact Backup: Name: Amy Bucher, PhD; Phone Number: 865-839-6158; Email: abucher@lirio.com

Study Locations

• United States
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Recruiting
      • Cone Health clinics
      • Contact: Sarah Deedat, PhD; Phone Number: 865.243.8000; Email: sdeedat@lirio.com
      • Contact: Amy Bucher, PhD; Phone Number: 865.243.8000; Email: abucher@lirio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Precision Nudging for Hypertension Management; All participants in this study will receive the digital health intervention.

Behavioral: Precision 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.; Other Names: Digital Health Intervention; Artificial Intelligence Driven Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical encounter behavioral outcome	Adherence with recommended clinical encounters given eligibility based on blood pressure readings and medication	0-18 months
Blood pressure reading clinical outcome	Blood pressure reading	0-18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement	Digital engagement (opens, clicks, responses, etc.)	0-18 months
Medication adherence behavioral outcome	Self-reported medication adherence	0-18 months
Self-monitoring of blood pressure behavioral outcome	Self-reported self-monitoring of blood pressure	0-18 months

Collaborators and Investigators

• Sponsor: Lirio
• Collaborators: Cone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Medication adherence; Health equity; Digital health intervention; Self-monitoring of blood pressure; Clinical encounters; Precision nudging; Behavioral reinforcement learning
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Hypertension; Medication Adherence
• Other Study ID Numbers: 0450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No