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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:
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I can use the study software in English or Spanish.

Timeline

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

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.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,400 Previous Clinical Trials
854,514 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,913 Previous Clinical Trials
47,757,314 Total Patients Enrolled
John DodsonPrincipal InvestigatorNew York Langone Health

Media Library

Regret Lottery Clinical Trial Eligibility Overview. Trial Name: NCT04114669 — N/A
High Blood Pressure Research Study Groups: Regret lottery, Control Condition
High Blood Pressure Clinical Trial 2023: Regret Lottery Highlights & Side Effects. Trial Name: NCT04114669 — N/A
Regret Lottery 2023 Treatment Timeline for Medical Study. Trial Name: NCT04114669 — N/A
~39 spots leftby Mar 2025