Building Engagement Using Financial Incentives Trial - Hypertension

NCT06195839 | Completed

• 1 other identifier: 2020-1600-BENH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this pilot clinical trial is to determine feasibility and explore whether immediate versus delayed patient financial incentives improve patient engagement with self-monitoring of blood pressure in patients with uncontrolled hypertension at Louisiana federally qualified health centers (FQHCs). The main questions it aims to answer are:

• Do patients randomized to receive financial incentives on a weekly basis during the study (immediate) have better adherence to blood pressure self-monitoring compared to patients randomized to receive financial incentives at the end of the study (delayed)?
• Do patients randomized to immediate financial incentives have better blood pressure control compared to patients randomized to delayed incentives? Participants will:
• attend a baseline visit to measure blood pressure, respond to a baseline survey, and receive remote patient monitoring devices and instructions to take home with them (home blood pressure monitor, wrist-worn sensor to track sleep activity, and associated apps)
• receive a random allocation to one of two groups: control condition (receive cash incentives at the end of the study for measuring blood pressure as instructed) or intervention condition (receive weekly cash incentives throughout the study for measuring blood pressure as instructed)
• use remote patient monitoring devices during a two month study period, receive weekly reports on adherence to blood pressure monitoring, and receive weekly financial incentives (intervention condition only)
• attend one follow-up visit at 2 months to measure their blood pressure, complete a follow-up survey, return the remote patient monitoring devices, and receive financial incentives for blood pressure monitoring (control condition only) Researchers will compare the immediate and delayed incentive groups to see if there are differences in blood pressure monitoring adherence rates and blood pressure control.

Conditions

Hypertension; Health Behavior; Healthcare Patient Acceptance; Patient Engagement; Adherence, Patient

Keywords

preventive healthcare; patient financial incentives; federally qualified health center (FQHC); remote patient monitoring (RPM); health services

Outcome Measures

Primary Outcomes (1)

• Between-group difference in weekly adherence to blood pressure monitoring

  Weekly adherence to blood pressure monitoring will be defined as the number of days that the participant used the home blood pressure monitor at least once, captured in the blood pressure monitoring app usage data.

  8 weeks

Secondary Outcomes (4)

• Between-group mean difference in change in systolic blood pressure

  8 weeks

• Between-group mean difference in change in diastolic blood pressure

  8 weeks

• Between-group difference in the proportion with blood pressure control (<130/80 mm Hg)

  8 weeks

• Between-group difference in the proportion with systolic blood pressure control (<130 mm Hg)

  8 weeks

Other Outcomes (4)

• Number of patient approached for recruitment

  3 months

• Number of patients assessed for eligibility

  3 months

• Number of patients enrolled

  3 months

Study Arms (2)

Immediate Financial Incentives for BP monitoring

EXPERIMENTAL

* instructions for participating in a 2-month remote patient monitoring program * home blood pressure monitor and associated smartphone app, which includes a module for logging medication-taking * wrist-worn sensor and associated smartphone app * weekly adherence feedback to home blood pressure monitoring * immediate financial incentives for home blood pressure monitoring distributed weekly

Behavioral: Remote Patient Monitoring; Behavioral: Self-monitoring of hypertension-related factors; Behavioral: Immediate financial incentives

Delayed Financial Incentives for BP monitoring

ACTIVE COMPARATOR

* instructions for participating in a 2-month remote patient monitoring program * home blood pressure monitor and associated smartphone app, which includes a module for logging medication-taking * wrist-worn sensor and associated smartphone app * weekly adherence feedback to home blood pressure monitoring * delayed financial incentives for home blood pressure monitoring distributed at the end of the study

Behavioral: Remote Patient Monitoring; Behavioral: Self-monitoring of hypertension-related factors; Behavioral: Delayed financial incentives

Interventions

Remote Patient Monitoring BEHAVIORAL

Participants will be given a home blood pressure machine and instructed to take their blood pressure twice/day (once in the morning and once at night) for the duration of the 2-month study. Blood pressure values will be immediately available in their patient-facing portal accessible via smartphone app, and patients will receive weekly feedback reports on their adherence to the home blood pressure monitoring protocol. Patients' blood pressure values will also be accessible to their clinical care team via an administrator portal, which will alert clinicians of any values above or below pre-specified clinical thresholds.

Delayed Financial Incentives for BP monitoring; Immediate Financial Incentives for BP monitoring

Self-monitoring of hypertension-related factors BEHAVIORAL

As part of self-monitoring of hypertension-related factors, the blood pressure monitoring patient-facing app will also prompt patients daily to report whether or not they took their blood pressure medication. in addition, participants will be provided with a wrist-worn sensor and instructed to wear it at night to track their sleep activity. Data on sleep activity will be available to patients through a separate patient-facing app accessible on their smartphone.

Delayed Financial Incentives for BP monitoring; Immediate Financial Incentives for BP monitoring

Immediate financial incentives BEHAVIORAL

Weekly financial incentives for measuring their blood pressure as instructed (up to $25/week: $5/day for up to 5 days/week)

Immediate Financial Incentives for BP monitoring

Delayed financial incentives BEHAVIORAL

Financial incentives for measuring their blood pressure as instructed in one payment at the end of the study (up to $25/week: $5/day for up to 5 days/week)

Delayed Financial Incentives for BP monitoring

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥40 years
• receive care at a participating FQHC
• taking blood pressure medication
• uncontrolled blood pressure at most recent clinic visit (systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥80 mm Hg)
• ability to understand and speak English
• able to access a smartphone

You may not qualify if:

• currently participating in another clinical trial or research study on blood pressure, medication-taking, or sleep
• unable or unwilling to give informed consent

Sponsors & Collaborators

• Tulane University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

CommuniHealth Services

Bastrop, Louisiana, 71220, United States

Location

David Raines Community Health Center

Shreveport, Louisiana, 71107, United States

Location

MeSH Terms

Conditions

Hypertension; Health Behavior; Patient Acceptance of Health Care; Patient Participation; Patient Compliance

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior; Treatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Marie Krousel-Wood, MD, MSPH

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 8, 2024
• Study Start: May 22, 2024
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (2)