Precision Nudging for Hypertension Management: Observational Study

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06354192
• Other study ID #: 0450
• Status: Not yet recruiting
• Start date: April 11, 2024
• Est. completion date: October 11, 2026

Study information

• Verified date: April 2024
• Source: Lirio
• Contact: E. Susanne Blazek, PhD
• Phone: 865-839-5539
• Email: sblazek[@]lirio.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12000
• Est. completion date: October 11, 2026
• Est. primary completion date: October 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• Non-English speaking.

• Globally unsubscribed.

• Locally unsubscribed.

• Deceased.

Related Conditions & MeSH terms

• Hypertension

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lirio	Cone Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical encounter behavioral outcome	Adherence with recommended clinical encounters given eligibility based on blood pressure readings and medication	0-18 months
Primary	Blood pressure reading clinical outcome	Blood pressure reading	0-18 months
Secondary	Engagement	Digital engagement (opens, clicks, responses, etc.)	0-18 months
Secondary	Medication adherence behavioral outcome	Self-reported medication adherence	0-18 months
Secondary	Self-monitoring of blood pressure behavioral outcome	Self-reported self-monitoring of blood pressure	0-18 months