Tailored Approaches to Stroke Health Education (TASHE)
13 de julio de 2020 actualizado por: Olajide Williams, Columbia University
The overarching goal of the proposed intervention is to reduce stroke disparities by overcoming pre-hospital barriers related to emergency stroke treatment and facilitating the appropriate response to acute stroke using a novel culturally-tailored and sustainable approach developed by an experienced transdisciplinary team.
Building on our previous work, in which the investigators have identified barriers to increasing stroke literacy and behavioral intent to call 911, the investigators will develop and evaluate the effectiveness of a novel, culturally tailored intervention using storytelling (narrative persuasion) in the form of two professionally produced 12-minute films (in English and Spanish), in minority populations in New York City (NYC).
Behavioral intent to call 911 will be assessed immediately after viewing the film, 6 months later, and one year later.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Stroke is the leading cause of adult disability and costs U.S. taxpayers >$60 billion annually.
Interventions designed to educate patients to seek treatment sooner when a stroke occurs may increase low rates of treatment with thrombolysis (current rates 3% national average).
Thrombolysis can increase the odds of minimal to zero disability from stroke if emergency medical system response times and in-hospital response times are optimized (maximum time from symptom onset to intravenous thrombolysis is 4.5 hours).
Black and Hispanic Americans have higher stroke incidence compared to Whites and are less likely to receive thrombolysis for acute stroke.
The latency to hospital arrival is largely dependent on patients' recognition of stroke symptoms, and immediate presentation to the emergency department.
The investigators have found very low stroke literacy rates among Blacks and Hispanics compared to Whites, which may, in part, be responsible for disparities in acute stroke treatment.
Tipo de estudio
Intervencionista
Inscripción (Actual)
290
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University Medical Center
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New York, New York, Estados Unidos, 10032
- Columbia University Medical Center, Neurological Institute
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
34 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- No prior history of stroke;
- High risk (defined as a history of one or more stroke risk factor (hypertension (HTN), diabetes, tobacco, abdominal obesity, heart disease, high cholesterol);
- Over age 34 years at onset of intervention (we have selected this age cut off due to the large increase in stroke incidence among minority groups at age 34 );
- Self-identified as Black or Hispanic; and
- Member of a church congregation who lives in a household with a telephone.
Exclusion Criteria:
- Participant is unable to give consent;
- A modified Rankin score > 4 at baseline;
- history of dementia; and
- terminal illness, or other medical illness resulting in mortality < 1 year.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention Group
Participants will receive education through a novel program called Stroke Education Film Viewing.
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A novel, culturally tailored intervention using storytelling (narrative persuasion) in the form of two professionally produced 12-min films (in English and Spanish), in minority populations in New York City.
|
|
Otro: Usual Care Group
Participants will receive education through Stroke Education Pamphlet Exposure.
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"Usual Care": Stroke Education pamphlet and brochure distribution.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Score on Stroke Action Test
Periodo de tiempo: Within one hour of stroke education intervention.
|
The Stroke Action Test (STAT) contains 21 items that name or describe stroke symptoms from all 5 groups of warning signs and 7 items that are nonstroke symptoms.
For each item, the respondent selects 1 of 4 options: call 911, call doctor, wait 1 hour, or wait 1 day.
For scoring purposes, each correct response receives 1 point; incorrect responses receive 0 points.
The total score is reported as percent of correct responses.
Scores range from 0% to 100% with a higher score indicating a better outcome.
|
Within one hour of stroke education intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Score on Stroke Action Test
Periodo de tiempo: Within six months of stroke education intervention.
|
The Stroke Action Test (STAT) contains 21 items that name or describe stroke symptoms from all 5 groups of warning signs and 7 items that are nonstroke symptoms.
For each item, the respondent selects 1 of 4 options: call 911, call doctor, wait 1 hour, or wait 1 day.
For scoring purposes, each correct response receives 1 point; incorrect responses receive 0 points.
The total score is reported as percent of correct responses.
Scores range from 0% to 100% with a higher score indicating a better outcome.
|
Within six months of stroke education intervention.
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|
Score on Stroke Action Test
Periodo de tiempo: Within one year of stroke education intervention.
|
The Stroke Action Test (STAT) contains 21 items that name or describe stroke symptoms from all 5 groups of warning signs and 7 items that are nonstroke symptoms.
For each item, the respondent selects 1 of 4 options: call 911, call doctor, wait 1 hour, or wait 1 day.
For scoring purposes, each correct response receives 1 point; incorrect responses receive 0 points.
The total score is reported as percent of correct responses.
Scores range from 0% to 100% with a higher score indicating a better outcome.
|
Within one year of stroke education intervention.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to emergency room after suffering a stroke
Periodo de tiempo: Up to 3.5 years post-intervention
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This measures the time in getting to the emergency room after having suffered a stroke.
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Up to 3.5 years post-intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Olajide. A Williams, MD, MS, Columbia University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Williams O, Teresi J, Eimicke JP, Abel-Bey A, Hassankhani M, Valdez L, Gomez Chan L, Kong J, Ramirez M, Ravenell J, Ogedegbe G, Noble JM. Effect of Stroke Education Pamphlets vs a 12-Minute Culturally Tailored Stroke Film on Stroke Preparedness Among Black and Hispanic Churchgoers: A Cluster Randomized Clinical Trial. JAMA Neurol. 2019 Oct 1;76(10):1211-1218. doi: 10.1001/jamaneurol.2019.1741.
- Ravenell J, Leighton-Herrmann E, Abel-Bey A, DeSorbo A, Teresi J, Valdez L, Gordillo M, Gerin W, Hecht M, Ramirez M, Noble J, Cohn E, Jean-Louis G, Spruill T, Waddy S, Ogedegbe G, Williams O. Tailored approaches to stroke health education (TASHE): study protocol for a randomized controlled trial. Trials. 2015 Apr 19;16:176. doi: 10.1186/s13063-015-0703-4.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
16 de abril de 2014
Finalización primaria (Actual)
8 de junio de 2017
Finalización del estudio (Actual)
1 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
22 de julio de 2013
Primero enviado que cumplió con los criterios de control de calidad
24 de julio de 2013
Publicado por primera vez (Estimar)
26 de julio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
13 de julio de 2020
Última verificación
1 de julio de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AAAK5853
- 1U54NS081765-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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