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Active, Not Recruiting

NCT Number: NCT06354192

Precision Nudging for Hypertension Management: 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cone Health clinics

Greensboro, North Carolina, 27401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Precision Nudging for Hypertension Management

Behavioral

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

Primary outcomes

  1. Clinical encounter behavioral outcome

    Time frame: 0-18 months

    Adherence with recommended clinical encounters given eligibility based on blood pressure readings and medication

  2. Blood pressure reading clinical outcome

    Time frame: 0-18 months

    Blood pressure reading

Secondary outcomes

  1. Engagement

    Time frame: 0-18 months

    Digital engagement (opens, clicks, responses, etc.)

  2. Medication adherence behavioral outcome

    Time frame: 0-18 months

    Self-reported medication adherence

  3. Self-monitoring of blood pressure behavioral outcome

    Time frame: 0-18 months

    Self-reported self-monitoring of blood pressure

Sponsors and collaborators

Lead sponsor

Lirio

Industry

Collaborators

  • Cone Health

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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