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Discharge Educational Strategies for Reduction of Vascular Events (DESERVE)

This study is currently recruiting participants.
Verified March 2017 by New York University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01836354
First Posted: April 19, 2013
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose
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.

Condition Intervention
Intracerebral Infarcts Ischemic Stroke Hemorrhagic Strokes TIA's Behavioral: DESERVE education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Discharge Educational Strategies for Reduction of Vascular Events

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: 6 months and 1 year ]
    change in overall blood pressure


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 800
Study Start Date: August 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: Usual Care
The usual care group will only receive written preparedness education, which is the standard care for the hospital.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836354


Contacts
Contact: Bernadette Boden-Albala, DrPH 212-659-9322

Locations
United States, New York
NYU Langone Medical Center Not yet recruiting
New York, New York, United States, 10016
Contact: Bernadette Boden-Albala, PhD         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Stanley Tuhrim, MD    212-241-7076    stanley.tuhrim@mountsinai.org   
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Joshua Stillman, MD    212-342-1698    jis5@columbia.edu   
Sponsors and Collaborators
New York University School of Medicine
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Bernadette Boden-Albala, DrPH Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01836354     History of Changes
Other Study ID Numbers: 14-00718
First Submitted: April 17, 2013
First Posted: April 19, 2013
Last Update Posted: March 24, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
stroke
interactive educational intervention
acute ischemic stroke
transient ischemic attack

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases