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

NYU Langone Health401 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

401

Conditions

High Blood Pressure

Interventions

Regret LotteryBEHAVIORAL

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Month 6

Secondary Outcomes

Antihypertensive Adherence

Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform. Adherence is measured as percentage of participants who "adhere" to treatment plan, defined as ≥ 80% of days covered.