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

High Blood Pressure Clinical Trial

— BETTER-BP  

Official title:

Behavioral Economics Trial To Enhance Regulation of Blood Pressure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04114669
• Other study ID #: 19-00952
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Stefany de Brito, BS
• Phone: 646-951-6796
• Email: stefany.debrito[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 435
• Est. completion date: September 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Behavioral:
• Control Condition
3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
• 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).

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Motivation measured with the Treatment Self-Regulation Questionnaire (TSRQ)		Baseline, 6 months, and 12 months
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	Adherence	Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform.	12 Months