Hemorrhagic Strokes, Intracerebral Infarcts, Ischemic Stroke, TIA's
Conditions
Keywords
stroke, interactive educational intervention, acute ischemic stroke, transient ischemic attack
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.
Interventions
BEHAVIORALDESERVE 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
Sponsors
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 6 months and 1 year | change in overall blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Incident | 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. |
Countries
United States
Outcome results
None listed