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临床试验/NCT03515681
NCT03515681已完成不适用

Retail Outlet Health Kiosk Hypertension Trial

Columbia University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
Total Number of Participants With Blood Pressure Control at 12 Months

研究概览

简要总结

The investigators propose to conduct pilot studies to support an application to conduct a fully powered randomized trial of a text messaging intervention to increase the rate of blood pressure control, defined as <140/90 mmHg, among hypertensive individuals using health kiosk blood pressure devices. These pilot studies will include testing of the intervention, recruitment, enrollment, and data collection procedures, and of the web-based interactions between the data coordinating center and higi Sh llc (Chicago, IL), which is the company that installs and maintains the health care kiosks and associated software infrastructure. Completion of these pilot studies will provide preliminary data to support an application for a full scale randomized controlled study. Potential for adaption is high because of alignment of retail outlets, kiosk providers, and consumers for health, wellness, and self-care.

详细描述

Cardiovascular disease (CVD) remains the leading cause of death in the U.S. as well as the leading cause of health care cost. Hypertension is the leading remediable risk factor for CVD in the U.S. and globally, with prevalence of 29% in U.S. adults. Recent data from NHANES indicate that blood pressure (BP) is not controlled, defined as <140/90 mmHg, in 48% of individuals in the U.S. with hypertension. Strategies to improve hypertension control have focused on the physician-patient interaction at the office visit, system factors in the health care provider system, and extension beyond the traditionally defined health care system. All have had some success but are limited by not reaching individuals outside the clinical encounter or by challenges of scale, scope, and standardization of blood pressure measurement outside the clinical setting. Retail outlet BP devices have the potential to address these limitations by providing free BP measurements to individuals outside the clinical setting and at all times the retail outlet is open. These automated devices are standardized and linked to software with the ability to collect data and provide information to individuals using these devices, thereby providing a platform for an intervention strategy. Higi is a privately owned company that provides health kiosks in retail outlets. Higi presently has 10,800 kiosks in the U.S. with 4,125 in Rite Aid pharmacies. More than 44 million BP measurements per year are obtained at higi kiosks. In the one-year period 7/1/15 to 6/30/16, approximately 727,000 individuals using higi kiosks recorded >3 systolic BP measurements >140/90 mmHg. The investigators propose to target this group using interactive text messaging to activate individuals to take actions to improve BP control. The primary endpoint will be BP control defined as <140/90 mmHg at 12 months post randomization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >3 systolic blood pressure measurements >140/90 mmHg (two in the previous 12 months + one at baseline)
  • Age 18-85 years
  • Weight <300 pounds
  • Has a cell phone
  • Can provide consent
  • Speaks English or Spanish

排除标准

  • 未提供

结局指标

主要结局

Total Number of Participants With Blood Pressure Control at 12 Months

时间窗: 12 months after randomization

Blood pressure (BP) control is defined as having BP \<140/90 mmHg.

次要结局

  • Mean Diastolic Pressure at 12 Months(12 months)
  • Total Number of Participants With Blood Pressure Control at 6 Months(6 months)
  • Total Number of Participants With Blood Pressure Control at 3 Months(3 months)
  • Mean Systolic Pressure at 12 Months(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven J. Shea

Professor of Medicine and Epidemiology

Columbia University

研究点 (1)

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