跳至主要内容
临床试验/NCT06712966
NCT06712966撤回不适用

EngageRx With Integrated Self-Measurement of Blood Pressure

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
70
试验地点
1
主要终点
Net Promoter Score

研究概览

简要总结

This pilot study will support use of EngageRx_SMBP for 70 patients in the UCSF General Internal Medicine practice. The goals of the pilot will be to assess usability and satisfaction of both patients and clinicians, and to describe BP-related process metrics and outcomes including time to intensification of BP medications and/or BP control.

详细描述

EngageRx is a programmable clinical decision support app that clinicians can access within the context of their electronic health record (EHR), and it can be connected with other technologies. We are integrating EngageRx with CareSimple, a company that provides a cellular-enabled BP device that patients can use for SMBP. CareSimple devices are FDA-cleared, can be shipped directly to patients, used by patients right out of the box (after installing batteries), and then deliver the SMBP measurements directly to the CareSimple cloud platform. There is no requirement to "sync" the device, and no need for patients to have a smartphone or set up an account or sign into anything. CareSimple supports a dashboard and portal that allows authorized users to sign in and access measurements for a patient, but this amounts to another barrier for clinicians to access the measurements; our integration with EngageRx will 1) allow clinicians to initiate SMBP monitoring for a patient with the click of a button (after confirming their shipping address and preferred language); 2) automatically register the patient in the CareSimple system, which triggers CareSimple to mail the patient the BP monitor device with instructions; and 3) automatically push the CareSimple SMBP measurements to EngageRx so they are available the next time the clinician opens EngageRx. The SMBP measurements will be used with EngageRx's internal algorithm, along with office BP measurements, to recommend BP management decisions to clinicians. We believe this integrated system, which we will refer to as EngageRx_SMBP, will make SMBP easy for clinicians and patients. We would like to determine if this system is truly easy to use for clinicians and providers, and whether it appears to facilitate the BP-related processes of care required for controlling hypertension.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • •Adult patient (18+ years old) with uncontrolled BP in an office visit
  • •Lowest SBP>140 or lowest DBP>90 during the visit at one of the Mt. Zion General Internal Medicine practices
  • •Speaks English or Spanish

排除标准

  • •If patient is unlikely to be able to use a home BP monitor
  • •Cannot understand the verbal consent

研究组 & 干预措施

EngageRx_SMBP

Experimental

Integrated SMBP monitoring using EngageRx_SMBP.

干预措施: EngageRx_SMBP (Other)

结局指标

主要结局

Net Promoter Score

时间窗: 3 months

This score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered "Promoters"; persons indicating 7 or 8 are "Passives"; and persons indicating 1-6 are "Detractors". The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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