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Discharge Educational Strategies for Reduction of Vascular Events (DESERVE)

Primary Purpose

Intracerebral Infarcts, Ischemic Stroke, Hemorrhagic Strokes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DESERVE education
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intracerebral Infarcts focused on measuring stroke, interactive educational intervention, acute ischemic stroke, transient ischemic attack

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NYU Langone Medical Center
  • Icahn School of Medicine at Mount Sinai
  • Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

DESERVE education

Usual Care

Arm Description

Intervention group will receive education on stroke preparedness plus risk factor reduction education, and help accessing follow up care with health workers.

The usual care group will only receive written preparedness education, which is the standard care for the hospital.

Outcomes

Primary Outcome Measures

Blood Pressure
change in overall blood pressure

Secondary Outcome Measures

Secondary Incident
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.

Full Information

First Posted
April 17, 2013
Last Updated
February 12, 2020
Sponsor
NYU Langone Health
Collaborators
Columbia University, National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT01836354
Brief Title
Discharge Educational Strategies for Reduction of Vascular Events
Acronym
DESERVE
Official Title
Discharge Educational Strategies for Reduction of Vascular Events
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Columbia University, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Infarcts, Ischemic Stroke, Hemorrhagic Strokes, TIA's
Keywords
stroke, interactive educational intervention, acute ischemic stroke, transient ischemic attack

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
552 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DESERVE education
Arm Type
Active Comparator
Arm Description
Intervention group will receive education on stroke preparedness plus risk factor reduction education, and help accessing follow up care with health workers.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
The usual care group will only receive written preparedness education, which is the standard care for the hospital.
Intervention Type
Behavioral
Intervention Name(s)
DESERVE education
Intervention Description
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
Primary Outcome Measure Information:
Title
Blood Pressure
Description
change in overall blood pressure
Time Frame
6 months and 1 year
Secondary Outcome Measure Information:
Title
Secondary Incident
Description
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.
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernadette Boden-Albala, DrPH
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34813082
Citation
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
Results Reference
derived
PubMed Identifier
32340524
Citation
Goldmann E, Jacoby R, Finfer E, Appleton N, Parikh NS, Roberts ET, Boden-Albala B. Positive Health Beliefs and Blood Pressure Reduction in the DESERVE Study. J Am Heart Assoc. 2020 May 5;9(9):e014782. doi: 10.1161/JAHA.119.014782. Epub 2020 Apr 28.
Results Reference
derived
PubMed Identifier
30304326
Citation
Boden-Albala B, Goldmann E, Parikh NS, Carman H, Roberts ET, Lord AS, Torrico V, Appleton N, Birkemeier J, Parides M, Quarles L. Efficacy of a Discharge Educational Strategy vs Standard Discharge Care on Reduction of Vascular Risk in Patients With Stroke and Transient Ischemic Attack: The DESERVE Randomized Clinical Trial. JAMA Neurol. 2019 Jan 1;76(1):20-27. doi: 10.1001/jamaneurol.2018.2926.
Results Reference
derived

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Discharge Educational Strategies for Reduction of Vascular Events

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