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NCT Number: NCT04114669

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

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.

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Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control condition

Behavioral

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

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).

Primary outcomes

  1. Change in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Month 6

    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. The average of the three measurements will be recorded as the value for that time period. The change is the difference in mean measurements during each time period.

  2. Change in Systolic Blood Pressure (SBP)

    Time frame: Month 6, Month 12

    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. The average of the three measurements will be recorded as the value for that time period. The change is the difference in mean measurements during each time period.

Secondary outcomes

  1. Percentage of Participants With Adequate Antihypertensive Adherence

    Time frame: Baseline, Month 6

    Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform. Adequate adherence defined as ≥ 80% of days adherent from baseline to 6 months. Adherence was calculated using the scheduling adherence metric, which is the proportion of days that a participant took their prescribed medication divided by the total number of days that they were expected to take medication in a given period.

  2. Percentage of Participants With Adequate Antihypertensive Adherence

    Time frame: Month 12

    Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform. Adequate adherence defined as ≥ 80% of days adherent from baseline to 6 months. Adherence was calculated using the scheduling adherence metric, which is the proportion of days that a participant took their prescribed medication divided by the total number of days that they were expected to take medication in a given period.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Behavioral Economics Trial To Enhance Regulation of Blood Pressure

Acronym: BETTER-BP

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2019
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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