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Discharge Educational Strategies for Reduction of Vascular Events (DESERVE)

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ClinicalTrials.gov Identifier: NCT01836354
Recruitment Status : Recruiting
First Posted : April 19, 2013
Last Update Posted : March 6, 2018
Sponsor:
Collaborators:
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
New York University School of Medicine

April 17, 2013
April 19, 2013
March 6, 2018
August 2012
December 2018   (Final data collection date for primary outcome measure)
Blood Pressure [ Time Frame: 6 months and 1 year ]
change in overall blood pressure
Same as current
Complete list of historical versions of study NCT01836354 on ClinicalTrials.gov Archive Site
Secondary Incident [ Time Frame: up to 3 years ]
A secondary outcome is when the patient has a new visit to the ED or another hospital; admission that it is not a stroke/TIA nor ICH. Instead, it might be a seizure, headache, migraine, anything else neurological.
Same as current
Not Provided
Not Provided
 
Discharge Educational Strategies for Reduction of Vascular Events
Discharge Educational Strategies for Reduction of Vascular Events
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Intracerebral Infarcts
  • Ischemic Stroke
  • Hemorrhagic Strokes
  • TIA's
Behavioral: DESERVE education
Those patients assigned to education will receive stroke comprehensive intervention which focuses on three main areas, Risk perception, Medication Adherence, and Patient-Physician Communication. We will test whether phone calls and visits with a health worker after discharge, videos and a workbook are linked to better control of blood pressure and other risk factors
  • Active Comparator: DESERVE education
    Intervention group will receive education on stroke preparedness plus risk factor reduction education, and help accessing follow up care with health workers.
    Intervention: Behavioral: DESERVE education
  • No Intervention: Usual Care
    The usual care group will only receive written preparedness education, which is the standard care for the hospital.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Bernadette Boden-Albala, DrPH 212-659-9322
United States
 
 
NCT01836354
14-00718
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
New York University School of Medicine
New York University School of Medicine
  • Columbia University
  • National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Bernadette Boden-Albala, DrPH Icahn School of Medicine at Mount Sinai
New York University School of Medicine
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP