Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP)

Study Overview
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Brief Summary
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BETTER-BP (Behavioral Economics Trial To Enhance Regulation of Blood Pressure) is a phase II, single-center, prospective, pragmatic randomized clinical trial within the New York City Health and Hospitals (NYC-H+H) system and NYU Langone Family Health Centers. The trial will recruit from 3 NYC-H+H ambulatory clinics as well as NYU Langone Family Health Centers, and will use a lottery incentive program to promote adherence to antihypertensive medication that will be delivered via smartphone for 6 months. The trial will randomize 435 patients with hypertension determined to have poor adherence (<80% adherence with antihypertensive medication), in a 2:1 (intervention:control) ratio. Baseline enrollment will occur over 36 months with an expected 12 months follow-up per participant.

Official Title
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Behavioral Economics Trial To Enhance Regulation of Blood Pressure

Conditions
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High Blood Pressure

Intervention / Treatment
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* Behavioral: Control Condition
* Behavioral: Regret Lottery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of hypertension. An active prescription for ≥1 antihypertensive medication (any of the following classes: thiazide diuretic, ACE inhibitor, angiotensin receptor blocker, beta blocker, calcium channel blocker, centrally acting alpha agonist, direct vasodilator). 1 ambulatory systolic blood pressure ≥140 mmHg (on therapy). Suboptimal adherence (self-report). Exclusion Criteria: Incarcerated Pregnant Unable to use study software (Way To Health) in English or Spanish Unable/unwilling to consent Clear barrier to technology use (e.g. visual or hearing impairment) Projected life expectancy <12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regret lottery<br>Will receive a lottery incentive (regret lottery) for 6 months | Behavioral: Regret Lottery<br>* Delivered by the Way to Health platform, installed on a smartphone and communicates with participants via text message.Participants are eligible to receive a potential cash reward if they are adherent with their antihypertensive medication the day before, which is monitored via electronic monitoring device (EMD) from AdhereTech. Each participant is assigned a 2-digit number for the trial, and each day the Way to Health platform randomly generates a 2-digit number. Participants will receive a prize if both digits match (1 in 100 chance) and will receive a prize of lesser value if one digit matches (18 in 100 chance). If they are not adherent with their medication, but would have won if they were adherent, they receive a text message that they would have won (regret component).<br>|
| Placebo Comparator: Control Condition<br>Will complete a total of 3 in-person study visits, approximately one hour each. | Behavioral: Control Condition<br>* 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure (SBP) | Three seated BPs will be measured after a rest period (5 minutes) using an automated device (Omron, Lake Forest, IL) which will reduce the potential for observer bias. | baseline to 12 Months | 
| Adherence | Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform. | 12 Months |