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

• ClinicalTrials.gov Identifier: NCT04114669
• Recruitment Status: Recruiting
• First Posted: October 3, 2019
• Last Update Posted: July 16, 2020
• Sponsor: NYU Langone Health
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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. The trial will recruit from 3 NYC-H+H ambulatory clinics, 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.

Condition or disease	Intervention/treatment	Phase
High Blood Pressure	Behavioral: Control Condition; Behavioral: Regret Lottery	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 435 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Behavioral Economics Trial To Enhance Regulation of Blood Pressure
• Actual Study Start Date: July 14, 2020
• Estimated Primary Completion Date: March 1, 2024
• Estimated Study Completion Date: July 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in Systolic Blood Pressure (SBP) [ Time Frame: baseline to 12 Months ]
   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.
2. Adherence [ Time Frame: 12 Months ]
   Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform.

Other Outcome Measures:

1. Motivation measured with the Treatment Self-Regulation Questionnaire (TSRQ) [ Time Frame: Baseline, 6 months, and 12 months ]
2. Self-efficacy measured by the Medication Adherence Self Efficacy Scale (MASES) [ Time Frame: 12 Months ]
   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.
3. Comorbidity burden will be evaluated (baseline) using the Charlson Comorbidity Index (CCI) [ Time Frame: Baseline ]
   weighted index that includes 19 chronic medical conditions, each of which is weighted on a scale of 1-6
4. Depression will be measured (baseline) by the PHQ-9 [ Time Frame: 12 Months ]
   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.
5. Patient-reported health status will be measured (baseline) using the Short Form 12 (SF-12). [ Time Frame: 12 Months ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Lysy Gonzalez; (646) 501-2646; lysy.gonzalez@nyulangone.org

Locations

United States, New York

NYU Langone Health; Recruiting

New York, New York, United States, 10016

Contact: Lysy Gonzalez 646-501-2646

Principal Investigator: John Dodson, MD

Sponsors and Collaborators

NYU Langone Health

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: John Dodson; New York Langone Health

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04114669
• Other Study ID Numbers: 19-00952
• First Posted: October 3, 2019
• Last Update Posted: July 16, 2020
• Last Verified: July 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases