What side effects are associated with this type of intervention?

Common treatments for high blood pressure include antihypertensive medications such as ACE inhibitors, calcium channel blockers, and diuretics. ACE inhibitors can cause side effects like cough, elevated blood potassium levels, and low blood pressure. Calcium channel blockers may lead to dizziness, headaches, swelling in the lower extremities, and constipation. Diuretics can result in increased urination, electrolyte imbalances, and dehydration. These side effects should be discussed with a healthcare provider to ensure proper management and adherence to the treatment plan.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure, including ACE inhibitors (e.g., lisinopril), angiotensin II receptor blockers (ARBs) (e.g., losartan), calcium channel blockers (CCBs) (e.g., amlodipine), and thiazide diuretics (e.g., hydrochlorothiazide). These medications are commonly prescribed to manage hypertension and reduce the risk of cardiovascular events. The Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP) aims to improve adherence to these antihypertensive medications through a lottery incentive program, delivered via smartphone, to ensure patients maintain their treatment regimens effectively.

What other types of research exist?

Promising alternatives to the Lottery Incentive Program for improving medication adherence in high blood pressure patients include: 1) Digital health interventions such as mobile health apps that provide reminders, educational content, and real-time feedback; 2) Personalized text messaging programs that offer tailored support and encouragement; 3) Gamification strategies that use game-like elements to motivate adherence; 4) Financial incentives directly tied to medication adherence milestones; 5) Patient navigation services that provide one-on-one support and guidance through healthcare systems; 6) Use of artificial intelligence to predict and address adherence barriers proactively.

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Lottery Incentive Program for High Blood Pressure (BETTER-BP Trial)

N/A

Recruiting

Led By John Dodson

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A diagnosis of hypertension.

1 ambulatory systolic blood pressure ≥140 mmHg (on therapy).

Must not have

Unable to use study software (Way To Health) in English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial encourages patients with high blood pressure, who don't take their medication regularly, to stick to their treatment by offering chances to win prizes.

Who is the study for?

The BETTER-BP trial is for individuals with high blood pressure who have been less than 80% adherent to their antihypertensive medication. Participants must have at least one blood pressure reading of ≥140 mmHg, a hypertension diagnosis, and be on prescribed medication like thiazide diuretics or ACE inhibitors. It's not for pregnant individuals, those unable to use the study app in English/Spanish, with technology barriers due to sensory impairments, incarceration, or life expectancy under 12 months.

What is being tested?

This phase II trial tests if a 'regret lottery' incentive program delivered via smartphone can improve adherence to blood pressure medications over six months. Of the 435 patients recruited from NYC clinics with poor adherence records, two-thirds will receive this intervention while the rest are in control condition without incentives.

What are the potential side effects?

Since this trial focuses on behavioral incentives rather than new medications or treatments, there aren't direct side effects from interventions being tested. However, participants may experience stress or disappointment if they do not win in the lottery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with high blood pressure.

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My blood pressure is 140 mmHg or higher, even with medication.

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I am currently taking medication for high blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can use the study software in English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence

Change in Systolic Blood Pressure (SBP)

Other study objectives

Comorbidity burden will be evaluated (baseline) using the Charlson Comorbidity Index (CCI)

Depression will be measured (baseline) by the PHQ-9

Patient-reported health status will be measured (baseline) using the Short Form 12 (SF-12).

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Regret lotteryExperimental Treatment1 Intervention

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

Group II: Control ConditionPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Regret Lottery

2009

N/A

~640

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include ACE inhibitors and ARBs, which relax blood vessels by inhibiting the renin-angiotensin system; beta-blockers, which reduce heart rate and the force of contraction; calcium channel blockers, which prevent calcium from entering heart and blood vessel cells, leading to relaxation; and diuretics, which help the body eliminate excess sodium and water, reducing blood volume. Understanding these mechanisms is crucial for patients as it highlights the importance of medication adherence to effectively manage blood pressure and reduce the risk of cardiovascular events. Programs like the Lottery Incentive Program aim to improve adherence by making patients more consistent with their medication, thereby enhancing treatment outcomes.

Fishbein's model of reasoned action and compliance behavior of hypertensive patients.Determinants of hypertension treatment adherence among a Chinese population using the therapeutic adherence scale for hypertensive patients.Understanding the quality chasm for hypertension control in diabetes: a structured review of "co-maneuvers" used in clinical trials.