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

Behavioral Economics Trial To Enhance Regulation of Blood Pressure

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 Overview

• Status: Recruiting
• Conditions: High Blood Pressure
• Intervention / Treatment: Behavioral: Regret Lottery; Behavioral: Control Condition

• Study Type: Interventional
• Enrollment (Estimated): 435
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefany de Brito, BS; Phone Number: 646-951-6796; Email: stefany.debrito@nyulangone.org
• Study Contact Backup: Name: Ayanna Horsford, BS; Phone Number: 929-996-2762; Email: ayanna.horsford@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Principal Investigator: John Dodson, MD
      • Contact: Stefany de Brito; Phone Number: 646-951-6796; Email: stefany.debrito@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regret lottery; Will receive a lottery incentive ("regret lottery") for 6 months	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).
Placebo Comparator: Control Condition; Will complete a total of 3 in-person study visits, approximately one hour each.	Behavioral: Control Condition; 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation measured with the Treatment Self-Regulation Questionnaire (TSRQ)		Baseline, 6 months, and 12 months
Self-efficacy measured by the Medication Adherence Self Efficacy Scale (MASES)	a 26-item scale used to assess patients' confidence in their ability to take Antihypertensive medications. Items are scored from 1 (not at all sure) to 4 (extremely sure) and a total score on the measure is computed by averaging across responses to all items. Higher scores indicate a greater level of self-efficacy. MASES will be administered at baseline, 6 months, and 12 months to evaluate change over time.	12 Months
Comorbidity burden will be evaluated (baseline) using the Charlson Comorbidity Index (CCI)	weighted index that includes 19 chronic medical conditions, each of which is weighted on a scale of 1-6	Baseline
Depression will be measured (baseline) by the PHQ-9	a validated screening tool consisting of 9 symptom questions that are scored on a scale of 0 ("not at all") to 3 ("nearly every day"). A score of ≥10 is consistent with at least moderate depression.	12 Months
Patient-reported health status will be measured (baseline) using the Short Form 12 (SF-12).	Physical (PCS) and Mental (MCS) Component Summary scores based on SF-12 responses will be calculated automatically using a proprietary algorithm (Optum Labs, Eden Prairie, MN), with higher scores indicating better health.	12 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: John Dodson, New York Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 19-00952

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No