Discharge Educational Strategies for Reduction of Vascular Events (DESERVE)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, Estados Unidos, 10016
- NYU Langone Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: DESERVE education
Intervention group will receive education on stroke preparedness plus risk factor reduction education, and help accessing follow up care with health workers.
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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
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Sin intervención: Usual Care
The usual care group will only receive written preparedness education, which is the standard care for the hospital.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood Pressure
Periodo de tiempo: 6 months and 1 year
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change in overall blood pressure
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6 months and 1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Secondary Incident
Periodo de tiempo: 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.
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up to 3 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bernadette Boden-Albala, DrPH, Icahn School of Medicine at Mount Sinai
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 14-00718
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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