Lottery Incentive Program for High Blood Pressure

(BETTER-BP Trial)

Overseen By Ayanna Horsford, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must be taking: Antihypertensives

Disqualifiers: Incarcerated, Pregnant, Technology barrier, others

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with high blood pressure adhere to their medication regimen. It uses a "regret lottery" incentive, delivered through a smartphone, to motivate participants to take their antihypertensive medication regularly. The trial seeks participants diagnosed with high blood pressure who have difficulty remembering or choosing to take their medication as prescribed. This trial might be a great fit for individuals who struggle to maintain their medication routine. As an unphased trial, it offers a unique opportunity to explore innovative methods for improving medication adherence.

Do I have to stop taking my current medications for this trial?

The trial does not specify that you need to stop taking your current medications. In fact, you need to have an active prescription for at least one antihypertensive medication to participate.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the study focuses on improving adherence to antihypertensive medication, it seems likely that you will continue your current medication.

What prior data suggests that this lottery incentive program is safe for promoting adherence to antihypertensive medication?

A previous study tested the concept of a "regret lottery" to help people remember to take their medication. This method uses a lottery to boost motivation without involving drugs or medical procedures, eliminating safety concerns associated with medications. Participants join a program where they can win a prize if they remember to take their blood pressure medicine. This approach showed no harmful effects, as it doesn't involve risky procedures like surgery or new drugs. Instead, it functions like a game that helps people stay on track with their health goals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for high blood pressure, which typically involve medications like ACE inhibitors or beta-blockers, the "Regret Lottery" introduces a behavioral twist. This experimental approach uses a lottery incentive to encourage patients to adhere to their treatment plans more consistently. Researchers are excited because this method taps into behavioral economics, potentially making medication adherence more engaging and effective. By turning treatment adherence into a game with rewards, it could significantly improve patient outcomes without introducing new drugs or side effects.

What evidence suggests that this lottery incentive program is effective for improving adherence to antihypertensive medication?

Research has shown that behavioral economic methods, such as the regret lottery, can improve medication adherence. This approach leverages natural human emotions, like the fear of missing out, to encourage adherence to medication schedules. Early results suggest these methods can enhance blood pressure management. In this trial, participants in the regret lottery arm will receive a lottery incentive for 6 months, creating a sense of potential loss if they fail to take their medication. Although specific data from the BETTER-BP trial is not yet available, similar methods have proven promising for individuals struggling with medication adherence. ^{1 2 5 6 7}

Who Is on the Research Team?

John Dodson, MD

Principal Investigator

New York Langone Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with high blood pressure.

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

I often forget to take my medication as prescribed.

Exclusion Criteria

Clear barrier to technology use (e.g. visual or hearing impairment)

Unable/unwilling to consent

Doctor thinks you may not live for another year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Enrollment

Baseline enrollment will occur over 36 months

36 months

Treatment

Participants receive a lottery incentive program to promote adherence to antihypertensive medication delivered via smartphone

6 months

3 in-person visits for control group

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Control Condition
• Regret Lottery

Trial Overview 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.

How Is the Trial Designed?

Group I: Regret lottery Experimental Treatment 1 Intervention

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

Group II: Control Condition Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Home blood pressure monitoring is more effective than clinic monitoring for diagnosing and treating hypertension, and it is cost beneficial for insurers, with estimated net savings ranging from $33 to $166 per member in the first year and up to $1364 over ten years.

The analysis indicates a strong return on investment for insurers, with returns ranging from $0.85 to $3.75 for every dollar spent in the first year, and from $7.50 to $19.34 in the long run, supporting the case for reimbursement of home BP monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-benefit analysis of home blood pressure monitoring in hypertension diagnosis and treatment: an insurer perspective. Arrieta, A., Woods, JR., Qiao, N., et al.[2023]

The BETTER-BP trial is testing a digitally-enabled incentive lottery to improve adherence to antihypertensive medications among 435 patients with poorly controlled hypertension over a 6-month period.

If effective, this innovative approach could significantly enhance medication adherence and lower systolic blood pressure in vulnerable populations, potentially leading to broader implementation in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study design of BETTER-BP: Behavioral economics trial to enhance regulation of blood pressure. Dodson, JA., Schoenthaler, A., Fonceva, A., et al.[2023]

An online spaced-education game for primary care clinicians significantly reduced the time it took for hypertensive patients to reach their blood pressure target, with a hazard ratio of 1.043 indicating a modest improvement.

The study involved 111 clinicians and analyzed 17,866 hypertensive periods among 14,336 patients, showing that the game was effective in enhancing clinician engagement and performance in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An online spaced-education game among clinicians improves their patients' time to blood pressure control: a randomized controlled trial. Kerfoot, BP., Turchin, A., Breydo, E., et al.[2022]

A randomized controlled trial showed that personalized physician invitations significantly increased health screening rates for diabetes and hypertension among Armenian adults, with an increase of about 15 percentage points for three of the interventions.

The most effective intervention was the personalized invitation with a conditional financial incentive, which resulted in a remarkable 31.2 percentage point increase in screening rates for both conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Invitations, incentives, and conditions: A randomized evaluation of demand-side interventions for health screenings. de Walque, D., Chukwuma, A., Ayivi-Guedehoussou, N., et al.[2022]

A randomized clinical trial involving 805 participants showed that various financial incentives significantly improved adherence to statin medication compared to a control group, with adherence rates reaching up to 87% in incentive groups.

Despite improved adherence, the study found no significant reduction in LDL-C levels among the incentive groups compared to the control, highlighting the need to measure actual health outcomes rather than just medication adherence in such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial. Barankay, I., Reese, PP., Putt, ME., et al.[2021]

Family doctors responded to stricter payment targets for controlling blood pressure by increasing treatment intensity, including a 1.2 percentage point rise in prescribing antihypertensive medications and more frequent blood pressure measurements, based on data from 107,148 patients.

However, the study also revealed that doctors engaged in 'gaming' behaviors, such as increasing the number of patients recorded as meeting the new targets by 3.1 percentage points, indicating that while treatment improved, the accuracy of reported outcomes may have been compromised.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family doctor responses to changes in target stringency under financial incentives. Wilding, A., Munford, L., Guthrie, B., et al.[2022]

The Achieve BP study assessed the willingness to accept (WTA) and willingness to pay (WTP) for blood pressure management among 38 patients with uncontrolled blood pressure, highlighting the importance of considering patient time and costs in evaluating treatment adherence.

Results showed that WTP was about twice as responsive as WTA, indicating that patients may value their willingness to pay for interventions more than their willingness to accept them, which can inform future health services research and cost-effectiveness evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Willingness to pay and willingness to accept in a patient-centered blood pressure control study. Gleason-Comstock, J., Streater, A., Goodman, A., et al.[2022]

Financial incentives based on behavioral economics significantly increased the odds of health behavior change, with participants having nearly four times higher odds of changing their behavior compared to those in the control group (odds ratio of 3.96).

The effectiveness of these financial incentives did not vary significantly by demographic factors such as gender, age, or education, but showed that Black participants had higher odds of behavior change compared to White participants when using conditional payments, while higher-income individuals had lower odds of change with a specific incentive structure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of behavioral economic incentive design and demographic characteristics in financial incentive-based approaches to changing health behaviors: a meta-analysis. Haff, N., Patel, MS., Lim, R., et al.[2022]

Displaying traffic fatality counts on highway signs as part of a safety campaign led to an increase in crashes during the campaign weeks, suggesting that the intervention may have unintended negative effects.

The negative impact of this campaign did not persist beyond the weeks it was active, indicating that overly attention-grabbing interventions can distract from safe driving behaviors rather than promote them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can behavioral interventions be too salient? Evidence from traffic safety messages. Hall, JD., Madsen, JM.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772487522000320

Study design of BETTER-BP: Behavioral economics trial to ... BETTER-BP is a pragmatic randomized trial conducted within 3 safety-net clinics in New York City: Bellevue Hospital Center, Gouveneur Hospital Center, and NYU ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36573193/

Study design of BETTER-BP: Behavioral economics trial to ... The trial will randomize 435 patients with poorly controlled hypertension and poor adherence (<80% days adherent) in a 2:1 ratio (intervention: ...

3. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC0D17598B8961CAA4A01A2FFCEB861BF/project-details/9798449

BETTER-BP (Behavioral Economics Trial To Enhance ... Behavioral economic approaches have recently been developed to enhance medication adherence; these strategies aim to leverage innately human tendencies (such as ...

4. researchgate.net researchgate.net/publication/365026362_Study_design_of_BETTER-BP_Behavioral_economics_trial_to_enhance_regulation_of_blood_pressure/fulltext/63ab19d703aad5368e45b1d6/Study-design-of-BETTER-BP-Behavioral-economics-trial-to-enhance-regulation-of-blood-pressure.pdf?origin=scientificContributions

Study design of BETTER-BP In this context, we designed the Behavioral Economics Trial To. Enhance Regulation of Blood Pressure (BETTER-BP). This pragmatic randomized ...

5. grantome.com grantome.com/index.php/grant/NIH/R01-HL148275-01

BETTER-BP (Behavioral Economics Trial To Enhance ... The results could lead to sustainable and scalable strategies to improve antihypertensive adherence and BP control among socioeconomically vulnerable patients.

6. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/1252/behavioral-economics-trial-enhance/

Behavioral Economics Trial To Enhance Regulation of Blood ... The trial will randomize 435 patients with hypertension determined to have poor adherence (<80% adherence with antihypertensive medication), in a 2:1 ( ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04114669/behavioral-economics-trial-to-enhance-regulation-of-blood-pressure-better-bp

Behavioral Economics Trial To Enhance Regulation of ... The trial will randomize 435 patients with hypertension determined to have poor adherence (<80% adherence with antihypertensive medication), in ...