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Clinical Trials/NCT01836354
NCT01836354
Completed
Not Applicable

Discharge Educational Strategies for Reduction of Vascular Events

NYU Langone Health3 sites in 1 country552 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracerebral Infarcts
Sponsor
NYU Langone Health
Enrollment
552
Locations
3
Primary Endpoint
Blood Pressure
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

DESERVE is a discharge education study using health workers to enroll and randomly assign 800 subjects diagnosed with TIA, or mild stroke to either risk factor education or usual care. Those patients assigned to education will receive stroke preparedness education plus risk factor reduction education, and help accessing follow up care with health workers. Those patients assigned to usual care will receive written stroke preparedness education. This protocol will evaluate the effectiveness of this intervention to reduce blood pressure, and individual stroke risk factors and future stroke risk.

Detailed Description

Stroke and its risk factors disproportionately affect minority populations, and secondary stroke prevention programs have had relatively little success. TIA and mild stroke patients with few after-affects also stay in the hospital for a shorter period of time, and leave without enough information about their risk for another stroke. Additionally, mild stroke and TIA patients often do not follow-up with neurologists after they leave the hospital. DESERVE is a discharge education study using health workers to enroll and randomly assign 800 subjects from MSSM, MSSM Queens and CUMC diagnosed with Transient Ischemic attack (TIA ), mild Ischemic stroke (IS) or mild Intracerebral Hemorrhage (ICH) to either risk factor education or usual care. Those patients assigned to education will receive education on stroke preparedness education plus risk factor reduction education, and help accessing follow up care with health workers. This education includes a power point presentation and a patient-paced workbook and video on Risk perception, Medication Adherence, and Patient-Physician Communication. To target the most appropriate mild IS/ICH and TIA survivors for participation in this proposal, we will focus on survivors with mild stroke and TIA, excluding those whose stroke deficits are severe enough to warrant discharge to a nursing home or to require 24-hour care. Those patients assigned to usual care will receive written stroke preparedness education. This protocol will evaluate the effectiveness of this intervention to reduce blood pressure, and individual stroke risk factors and future stroke risk. Additionally, we will evaluate the ability of the these strategies to conduct education to affect positive change in taking medications as directed, stroke knowledge 6 months and 12 months after hospital admission, attendance at follow-up health care appointments, and cost-effectiveness. After 1 year participants will be followed quarterly for up to 3 years to track events.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
November 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with mild ischemic cerebral infarction or mild intracerebral hemorrhage (NIHSS \< 5) or TIA based on a clinical definition of focal neurologic deficits consistent with a single vascular territory of the brain
  • Aged greater than 18 years at onset of event
  • Resident of NY Metropolitan community in home with land or cell phone.
  • Vascular risk factors including HTN history or elevated blood pressure (\>130/85 mmHg) at the time of discharge, smoking, diabetes or metabolic syndrome
  • Discharge to home
  • English or Spanish Speaker

Exclusion Criteria

  • Patients unable to give informed consent
  • Discharged to long-term nursing home or requiring 24 hour care.
  • A Modified Rankin score \> 2 at baseline
  • Pre-stroke dementia history.
  • Patients with end stage cancer, or other medical conditions resulting in mortality less than 1 year.
  • Patient does not speak English or Spanish.

Outcomes

Primary Outcomes

Blood Pressure

Time Frame: 6 months and 1 year

change in overall blood pressure

Secondary Outcomes

  • Secondary Incident(up to 3 years)

Study Sites (3)

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