Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk factor: Protocol of a RCT

J Stroke Cerebrovasc Dis. 2021 Aug;30(8):105815. doi: 10.1016/j.jstrokecerebrovasdis.2021.105815. Epub 2021 May 27.


Background: Geographical and racial disparities in stroke outcomes are especially prominent in the Southeastern United States, which represents a region more heavily burdened with stroke compared to the rest of the country. While stroke is eminently preventable, particularly via blood pressure control, fewer than one third of patients with a stroke have their blood pressure controlled ≥ 75% of the time, and low consistency of blood pressure control is linked to higher stroke risk.

Objective: To demonstrate that a mHealth technology-centered, integrated approach can effectively improve sustained blood pressure control among stroke patients (half of whom will be Black).

Design: The Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor is a prospective randomized controlled trial, which will include a cohort of 200 patients with a stroke, encountered at two major safety net health care systems in South Carolina. The intervention comprises utilization of a Vaica electronic pill tray & blue-toothed UA-767Plus BT blood pressure device and a dedicated app installed on patients' smart phones for automatic relay of data to a central server. Providers will follow care protocols based on expert consensus practice guidelines to address optimal blood pressure management.

Study outcomes: Primary outcome is systolic blood pressure at 12-months, which is the major modifiable step to stroke event rate reduction. Secondary endpoints include control of other stroke risk factors, medication adherence, functional status, and quality of life.

Discussion: We anticipate that a successful intervention will serve as a scalable model of effective chronic blood pressure management after stroke, to bridge racial and geographic disparities in stroke outcomes in the United States.

Trial registration: - NCT03401489.

Keywords: Hypertension; Mhealth; Risk factor; Secondary prevention; Stroke.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Black or African American
  • Blood Pressure / drug effects*
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Female
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Hypertension / diagnosis
  • Hypertension / drug therapy*
  • Hypertension / ethnology
  • Hypertension / physiopathology
  • Male
  • Medication Adherence
  • Middle Aged
  • Mobile Applications
  • Multicenter Studies as Topic
  • Prospective Studies
  • Randomized Controlled Trials as Topic
  • Risk Assessment
  • Risk Factors
  • Safety-net Providers*
  • Secondary Prevention*
  • Self Care*
  • Smartphone
  • South Carolina
  • Stroke / diagnosis
  • Stroke / ethnology
  • Stroke / prevention & control*
  • Telemedicine*
  • Time Factors
  • Treatment Outcome
  • White People
  • Young Adult

Associated data