High Blood Pressure
Conditions
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 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.
Interventions
BEHAVIORALControl Condition
3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
BEHAVIORALRegret 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).
Sponsors
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) | Baseline, Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adequate Antihypertensive Adherence | Baseline, Month 6 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn Dodson
New York Langone Health
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 246 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 154 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 23 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 83 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 400 participants |
| Sex: Female, Male Female | 242 Participants |
| Sex: Female, Male Male | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 265 | 0 / 135 |
| other Total, other adverse events | 60 / 265 | 21 / 135 |
| serious Total, serious adverse events | 30 / 265 | 14 / 135 |
Outcome results
None listed