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

NCT04114669 | Completed

• 1 other identifier: 19-00952
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

High Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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, Month 6

Secondary Outcomes (1)

• Antihypertensive Adherence

  Baseline, Month 6

Study Arms (2)

Regret lottery

EXPERIMENTAL

Will receive a lottery incentive ("regret lottery") for 6 months

Behavioral: Regret Lottery

Control Condition

PLACEBO COMPARATOR

Will complete a total of 3 in-person study visits, approximately one hour each.

Behavioral: Control Condition

Interventions

Regret Lottery BEHAVIORAL

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).

Regret lottery

Control Condition BEHAVIORAL

3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.

Control Condition

Eligibility Criteria

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

You may qualify if:

• 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).
• ambulatory systolic blood pressure ≥140 mmHg (on therapy).
• Suboptimal adherence (self-report).

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• John Dodson

  New York Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: October 3, 2019
• Study Start: July 14, 2020
• Primary Completion: May 12, 2025
• Study Completion: September 12, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)