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

NCT ID: NCT04114669

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-14

Study Completion Date

2025-09-12

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.

Detailed Description

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Conditions

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High Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Regret lottery

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

Group Type EXPERIMENTAL

Regret Lottery

Intervention Type 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).

Control Condition

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

Group Type PLACEBO_COMPARATOR

Control Condition

Intervention Type BEHAVIORAL

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

Interventions

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Control Condition

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

Intervention Type BEHAVIORAL

Regret Lottery

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).

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Dodson

Role: PRINCIPAL_INVESTIGATOR

New York Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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19-00952

Identifier Type: -

Identifier Source: org_study_id