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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial

Authors: Tanya M Spruill, Olajide Williams, Jeanne A Teresi, Susan Lehrer, Liliana Pezzin, Salina P Waddy, Ronald M Lazar, Stephen K Williams, Girardin Jean-Louis, Joseph Ravenell, Sunil Penesetti, Albert Favate, Judith Flores, Katherine A Henry, Anne Kleiman, Steven R Levine, Richard Sinert, Teresa Y Smith, Michelle Stern, Helen Valsamis, Gbenga Ogedegbe

Published in: Trials | Issue 1/2015

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Abstract

Background

Black and Hispanic stroke survivors experience higher rates of recurrent stroke than whites. This disparity is partly explained by disproportionately higher rates of uncontrolled hypertension in these populations. Home blood pressure telemonitoring (HBPTM) and nurse case management (NCM) have proven efficacy in addressing the multilevel barriers to blood pressure (BP) control and reducing BP. However, the effectiveness of these interventions has not been evaluated in stroke patients. This study is designed to evaluate the comparative effectiveness, cost-effectiveness and sustainability of these two telehealth interventions in reducing BP and recurrent stroke among high-risk Black and Hispanic stroke survivors with uncontrolled hypertension.

Methods/Design

A total of 450 Black and Hispanic patients with recent nondisabling stroke and uncontrolled hypertension are randomly assigned to one of two 12-month interventions: 1) HBPTM with wireless feedback to primary care providers or 2) HBPTM plus individualized, culturally-tailored, telephone-based NCM. Patients are recruited from stroke centers and primary care practices within the Health and Hospital Corporations (HHC) Network in New York City. Study visits occur at baseline, 6, 12 and 24 months. The primary outcomes are within-patient change in systolic BP at 12 months, and the rate of stroke recurrence at 24 months. The secondary outcome is the comparative cost-effectiveness of the interventions at 12 and 24 months; and exploratory outcomes include changes in stroke risk factors, health behaviors and treatment intensification. Recruitment for the stroke telemonitoring hypertension trial is currently ongoing.

Discussion

The combination of two established and effective interventions along with the utilization of health information technology supports the sustainability of the HBPTM + NCM intervention and feasibility of its widespread implementation. Results of this trial will provide strong empirical evidence to inform clinical guidelines for management of stroke in minority stroke survivors with uncontrolled hypertension. If effective among Black and Hispanic stroke survivors, these interventions have the potential to substantially mitigate racial and ethnic disparities in stroke recurrence.

Trial registration

ClinicalTrials.gov NCT02011685. Registered 10 December 2013.
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Metadata
Title
Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial
Authors
Tanya M Spruill
Olajide Williams
Jeanne A Teresi
Susan Lehrer
Liliana Pezzin
Salina P Waddy
Ronald M Lazar
Stephen K Williams
Girardin Jean-Louis
Joseph Ravenell
Sunil Penesetti
Albert Favate
Judith Flores
Katherine A Henry
Anne Kleiman
Steven R Levine
Richard Sinert
Teresa Y Smith
Michelle Stern
Helen Valsamis
Gbenga Ogedegbe
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0605-5

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