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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02011685 . Registered 10 December 2013.
authors: New York University School of Medicine, 227 East 30th Street, Room 640, 10016, New York, NY, USA. Tanya.Spruill@nyumc.org.
authors: Tanya M
authors: TM
authors: Spruill
authors: Department of Neurology, Columbia University Medical School, New York, NY, USA. ow11@cumc.columbia.edu.
authors: Olajide
authors: O
authors: Williams
authors: Research Division, Hebrew Home at Riverdale, Bronx, NY, USA. Teresimeas@aol.com.|Columbia University Stroud Center and New York State Psychiatric Institute, New York, NY, USA. Teresimeas@aol.com.
authors: Jeanne A
authors: JA
authors: Teresi
authors: Health and Hospitals Corporation, New York, NY, USA. Susan.Lehrer@nychhc.org.
authors: Susan
authors: S
authors: Lehrer
authors: Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA. lpezzin@mcw.edu.
authors: Liliana
authors: L
authors: Pezzin
authors: Office of Clinical Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA. waddysp@ninds.nih.gov.
authors: Salina P
authors: SP
authors: Waddy
authors: Department of Neurology, Columbia University Medical School, New York, NY, USA. ral22@cumc.columbia.edu.
authors: Ronald M
authors: RM
authors: Lazar
authors: New York University School of Medicine, 227 East 30th Street, Room 640, 10016, New York, NY, USA. Stephen.Williams@nyumc.org.
authors: Stephen K
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authors: Williams
authors: New York University School of Medicine, 227 East 30th Street, Room 640, 10016, New York, NY, USA. Girardin.Jean-Louis@nyumc.org.
authors: Girardin
authors: G
authors: Jean-Louis
authors: New York University School of Medicine, 227 East 30th Street, Room 640, 10016, New York, NY, USA. Joseph.Ravenell@nyumc.org.
authors: Joseph
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authors: Ravenell
authors: New York University School of Medicine, 227 East 30th Street, Room 640, 10016, New York, NY, USA. Sunil.Penesetti@nyumc.org.
authors: Sunil
authors: S
authors: Penesetti
authors: Department of Neurology, New York University School of Medicine, New York, NY, USA. Albert.Favate@nyumc.org.
authors: Albert
authors: A
authors: Favate
authors: Woodhull Medical Center, New York, NY, USA. Judith.Flores@woodhullhc.nychhc.org.
authors: Judith
authors: J
authors: Flores
authors: Department of Neurology, New York University School of Medicine, New York, NY, USA. Katherine.Henry@nyumc.org.|Bellevue Hospital Center, New York, NY, USA. Katherine.Henry@nyumc.org.
authors: Katherine A
authors: KA
authors: Henry
authors: Harlem Hospital, New York, NY, USA. kleimana@nychhc.org.
authors: Anne
authors: A
authors: Kleiman
authors: Department of Neurology, SUNY Downstate Medical Center, Brooklyn, NY, USA. Steven.Levine@downstate.edu.|Department of Emergency Medicine, SUNY Downstate Medical Center, Brooklyn, NY, USA. Steven.Levine@downstate.edu.|The Department of Neurology, Kings County Hospital Center, Brooklyn, NY, USA. Steven.Levine@downstate.edu.
authors: Steven R
authors: SR
authors: Levine
authors: Department of Emergency Medicine, Kings County Health Center, Brooklyn, NY, USA. nephron1@gmail.com.
authors: Richard
authors: R
authors: Sinert
authors: Department of Emergency Medicine, Kings County Health Center, Brooklyn, NY, USA. teresaemergencymd@gmail.com.
authors: Teresa Y
authors: TY
authors: Smith
authors: Jacobi Medical Center, New York, NY, USA. michelle.stern@nbhn.net.
authors: Michelle
authors: M
authors: Stern
authors: Department of Neurology, SUNY Downstate Medical Center, Brooklyn, NY, USA. Helen.Valsamis@nychhc.org.|Neurology Service, Kings County Hospital, Brooklyn, NY, USA. Helen.Valsamis@nychhc.org.
authors: Helen
authors: H
authors: Valsamis
authors: New York University School of Medicine, 227 East 30th Street, Room 640, 10016, New York, NY, USA. Olugbenga.Ogedegbe@nyumc.org.
authors: Gbenga
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authors: Ogedegbe
mesh_terms: D001741:Black or African American; D000959:Antihypertensive Agents / Q000627:therapeutic use; D018660:Blood Pressure Monitoring, Ambulatory / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D019090:Case Management / Q000191:economics; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004867:Equipment Design; D017048:Health Care Costs; D007722:Health Knowledge, Attitudes, Practice; D054625:Healthcare Disparities / Q000208:ethnology; D006630:Hispanic or Latino; D006801:Humans; D006973:Hypertension / Q000175:diagnosis* / Q000191:economics / Q000208:ethnology / Q000451:nursing* / Q000503:physiopathology; D009519:New York City; D010349:Patient Compliance; D010353:Patient Education as Topic; D011237:Predictive Value of Tests; D012008:Recurrence; D012107:Research Design; D012307:Risk Factors; D020521:Stroke / Q000175:diagnosis / Q000191:economics / Q000208:ethnology / Q000451:nursing* / Q000503:physiopathology; D017216:Telemedicine / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D013686:Telemetry / Q000191:economics / Q000295:instrumentation; D059015:Wireless Technology
chemical_list: D000959:Antihypertensive Agents