Building Engagement Using Financial Incentives Trial - Hypertension

Hypertension Clinical Trial

— BENEFIT-H  

Official title:

Building Engagement Using Financial Incentives Trial - Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06195839
• Other study ID #: 2020-1600-BENH
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Tulane University
• Contact: Erin Peacock, PhD, MPH
• Phone: 504-988-1075
• Email: epeacoc[@]tulane.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• currently participating in another clinical trial or research study on blood pressure, medication-taking, or sleep

• unable or unwilling to give informed consent

Related Conditions & MeSH terms

• Adherence, Patient
• Health Behavior
• Hypertension
• Patient Engagement

Intervention

Behavioral:
• Remote Patient Monitoring
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.
• Self-monitoring of hypertension-related factors
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.
• Immediate financial incentives
Weekly financial incentives for measuring their blood pressure as instructed (up to $25/week: $5/day for up to 5 days/week)
• Delayed financial incentives
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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patient approached for recruitment	Number of patients with reachable phone numbers or approached in clinic	3 months
Other	Number of patients assessed for eligibility	Number of patients who begin eligibility screener	3 months
Other	Number of patients enrolled	Number of patients who consent and are randomized	3 months
Other	Number of patients who receive intended treatment	Proportion of total possible financial incentive received	2 months
Primary	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	Between-group mean difference in change in systolic blood pressure	Blood pressure will be measured at baseline and 8-week follow-up by a certified Clinical Research Coordinator using the average of three seated blood pressure measurements and in accordance with American Heart Association (AHA) guidelines.	8 weeks
Secondary	Between-group mean difference in change in diastolic blood pressure	Blood pressure will be measured at baseline and 8-week follow-up by a certified Clinical Research Coordinator using the average of three seated blood pressure measurements and in accordance with American Heart Association (AHA) guidelines.	8 weeks
Secondary	Between-group difference in the proportion with blood pressure control (<130/80 mm Hg)	Blood pressure will be measured at baseline and 8-week follow-up by a certified Clinical Research Coordinator using the average of three seated blood pressure measurements and in accordance with American Heart Association (AHA) guidelines. Blood pressure control will be defined as systolic <130 mm Hg and diastolic <80 mm Hg.	8 weeks
Secondary	Between-group difference in the proportion with systolic blood pressure control (<130 mm Hg)	Blood pressure will be measured at baseline and 8-week follow-up by a certified Clinical Research Coordinator using the average of three seated blood pressure measurements and in accordance with American Heart Association (AHA) guidelines. Systolic blood pressure control will be defined as systolic <130 mm Hg.	8 weeks