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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regret lottery | Experimental | Will receive a lottery incentive ("regret lottery") for 6 months |
|
| Control Condition | Placebo Comparator | Will complete a total of 3 in-person study visits, approximately one hour each. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Condition | Behavioral | 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. The average of the three measurements will be recorded as the value for that time period. The change is the difference in mean measurements during each time period. | Baseline, Month 6 |
| 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. The average of the three measurements will be recorded as the value for that time period. The change is the difference in mean measurements during each time period. | Month 6, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adequate Antihypertensive Adherence | Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform. Adequate adherence defined as ≥ 80% of days adherent from baseline to 6 months. Adherence was calculated using the scheduling adherence metric, which is the proportion of days that a participant took their prescribed medication divided by the total number of days that they were expected to take medication in a given period. |
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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).
Suboptimal adherence (self-report).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Dodson | New York Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Regret Lottery | Will receive a lottery incentive ("regret lottery") for 6 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). |
| FG001 | Control Condition | Will complete a total of 3 in-person study visits, approximately one hour each. Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Regret Lottery | Will receive a lottery incentive ("regret lottery") for 6 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. The average of the three measurements will be recorded as the value for that time period. The change is the difference in mean measurements during each time period. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, Month 6 |
|
12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regret Lottery | Will receive a lottery incentive ("regret lottery") for 6 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Pena | NYU Langone Health | 646-618-2841 | stephanie.pena@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2023 | Apr 28, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2023 | Jan 15, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Regret Lottery | Behavioral | 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). |
|
| Baseline, Month 6 |
| Percentage of Participants With Adequate Antihypertensive Adherence | Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform. Adequate adherence defined as ≥ 80% of days adherent from baseline to 6 months. Adherence was calculated using the scheduling adherence metric, which is the proportion of days that a participant took their prescribed medication divided by the total number of days that they were expected to take medication in a given period. | Month 12 |
| Lost to Follow-up |
|
| BG001 | Control Condition | Will complete a total of 3 in-person study visits, approximately one hour each. Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Control Condition | Will complete a total of 3 in-person study visits, approximately one hour each. Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 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. The average of the three measurements will be recorded as the value for that time period. The change is the difference in mean measurements during each time period. | Posted | Mean | 95% Confidence Interval | mmHg | Month 6, Month 12 |
|
|
|
| Secondary | Percentage of Participants With Adequate Antihypertensive Adherence | Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform. Adequate adherence defined as ≥ 80% of days adherent from baseline to 6 months. Adherence was calculated using the scheduling adherence metric, which is the proportion of days that a participant took their prescribed medication divided by the total number of days that they were expected to take medication in a given period. | Posted | Number | Percentage of participants | Baseline, Month 6 |
|
|
|
| Secondary | Percentage of Participants With Adequate Antihypertensive Adherence | Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform. Adequate adherence defined as ≥ 80% of days adherent from baseline to 6 months. Adherence was calculated using the scheduling adherence metric, which is the proportion of days that a participant took their prescribed medication divided by the total number of days that they were expected to take medication in a given period. | Posted | Number | Percentage of participants | Month 12 |
|
|
|
| 2 |
| 265 |
| 30 |
| 265 |
| 60 |
| 265 |
| EG001 | Control Condition | Will complete a total of 3 in-person study visits, approximately one hour each. Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months. | 0 | 135 | 14 | 135 | 21 | 135 |
| Renal/Electrolyte Abnormality | Renal and urinary disorders | Systematic Assessment |
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| Fall Related Injuries | General disorders | Systematic Assessment |
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| Abdominal Pain | General disorders | Systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
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| Elective Surgery | Surgical and medical procedures | Systematic Assessment |
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| Pancreatitis | General disorders | Systematic Assessment |
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| Pulmonary Embolism | General disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment |
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| Renal/Electrolyte Abnormality | Renal and urinary disorders | Systematic Assessment |
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| Fall Related Injuries | General disorders | Systematic Assessment |
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| Syncope | General disorders | Systematic Assessment |
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