Discharge Educational Strategies for Reduction of Vascular Events (DESERVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by New York University School of Medicine
Sponsor:
Collaborators:
Columbia University
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01836354
First received: April 17, 2013
Last updated: April 8, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Discharge Educational Strategies for Reduction of Vascular Events

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
    change in overall blood pressure


Secondary Outcome Measures:
  • Secondary Incident [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    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: June 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836354

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

Locations
United States, New York
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   
NYU Langone Medical Center Not yet recruiting
New York, New York, United States, 10016
Contact: Bernadette Boden-Albala, PhD         
Sponsors and Collaborators
New York University School of Medicine
Columbia University
Investigators
Principal Investigator: Bernadette Boden-Albala, DrPH Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01836354     History of Changes
Other Study ID Numbers: GCO 12-0699
Study First Received: April 17, 2013
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Intracranial Hemorrhages
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Hemorrhage

ClinicalTrials.gov processed this record on August 20, 2014