Behavioral Economics Trial To Enhance Regulation of Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure (SBP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Incarcerated
- •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
研究组 & 干预措施
Regret lottery
Will receive a lottery incentive ("regret lottery") for 6 months
干预措施: Regret Lottery (Behavioral)
Control Condition
Will complete a total of 3 in-person study visits, approximately one hour each.
干预措施: Control Condition (Behavioral)
结局指标
主要结局
Change in Systolic Blood Pressure (SBP)
时间窗: 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.
Change in Systolic Blood Pressure (SBP)
时间窗: Month 6, Month 12
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.
次要结局
- Percentage of Participants With Adequate Antihypertensive Adherence(Baseline, Month 6)
- Percentage of Participants With Adequate Antihypertensive Adherence(Month 12)