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


Journal

Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
ISSN: 1532-8511
Titre abrégé: J Stroke Cerebrovasc Dis
Pays: United States
ID NLM: 9111633

Informations de publication

Date de publication:
Aug 2021
Historique:
received: 07 09 2020
revised: 31 03 2021
accepted: 05 04 2021
pubmed: 31 5 2021
medline: 28 7 2021
entrez: 30 5 2021
Statut: ppublish

Résumé

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. 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). 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. 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. 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. ClinicalTrials.gov - NCT03401489.

Sections du résumé

BACKGROUND 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 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 METHODS
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 RESULTS
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 CONCLUSIONS
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 BACKGROUND
ClinicalTrials.gov - NCT03401489.

Identifiants

pubmed: 34052785
pii: S1052-3057(21)00218-4
doi: 10.1016/j.jstrokecerebrovasdis.2021.105815
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT03401489']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

105815

Informations de copyright

Published by Elsevier Inc.

Auteurs

Ashley M Wabnitz (AM)

College of Medicine, Medical University of South Carolina, Charleston, SC, United States. Electronic address: wabnitz@musc.edu.

Jessica Chandler (J)

College of Nursing, Medical University of South Carolina, Charleston, SC, United States. Electronic address: chandje@musc.edu.

Frank Treiber (F)

College of Medicine, Medical University of South Carolina, Charleston, SC, United States; College of Nursing, Medical University of South Carolina, Charleston, SC, United States. Electronic address: treiberf@musc.edu.

Souvik Sen (S)

College of Medicine, University of South Carolina School of Medicine, Columbia, SC, United States. Electronic address: Souvik.Sen@uscmed.sc.edu.

Carolyn Jenkins (C)

College of Nursing, Medical University of South Carolina, Charleston, SC, United States. Electronic address: jenkinsc@musc.edu.

Jill C Newman (JC)

College of Nursing, Medical University of South Carolina, Charleston, SC, United States. Electronic address: newmanji@musc.edu.

Martina Mueller (M)

College of Nursing, Medical University of South Carolina, Charleston, SC, United States. Electronic address: muellerm@musc.edu.

Ariana Tinker (A)

College of Medicine, Medical University of South Carolina, Charleston, SC, United States. Electronic address: tinkera@musc.edu.

Amelia Flynn (A)

College of Medicine, University of South Carolina School of Medicine, Columbia, SC, United States. Electronic address: Amelia.Flynn@uscmed.sc.edu.

Raelle Tagge (R)

Northern California Institute of Research and Education, United States. Electronic address: raelle.tagge@ncire.org.

Bruce Ovbiagele (B)

Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: bruce.ovbiagele@va.gov.

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