Culturally Tailoring a Stroke Intervention in Community Senior Centers (SPIRP)
6 de diciembre de 2019 actualizado por: Catherine A. Sarkisian, University of California, Los Angeles
Implementing and Testing a Culturally-Tailored Stroke Risk Factor Reduction Intervention in Community Senior Centers
Stroke is a cruel disease that disproportionately kills and disables African-Americans, Latinos, Chinese-Americans and Korean-Americans; seniors with high blood pressure are at particularly high risk. There is a higher incidence of hemorrhagic stroke in African Americans, Latinos, and Chinese Americans relative to non-Latino whites. Asian-Americans have up to 1.4 higher relative risk of stroke death compared to U.S. non-Latino whites. A critical need therefore exists for a sustainable and scalable mechanism to disseminate culturally-tailored stroke knowledge/prevention education in community-based settings where large numbers of these high-risk ethnic minority older adult groups are regularly served, such as in federally funded Multipurpose Senior Centers (MPCs) that exist across the nation (16 of which are in Los Angeles alone).
The overall objective of the proposed study is to develop and test the implementation of a training program for case managers at senior centers to implement a stoke knowledge/prevention education program among four high-risk ethnic minority older adult groups--Korean-American, Chinese-American, African-American, Latinos. We propose to develop a culturally-tailored case manager training curriculum, implement the training at 4 community-based sites, and evaluate the training model using a randomized wait-list controlled trial (n=244) testing the hypothesis that training case managers will decrease older adult participants' stroke risk in a sustainable fashion through increasing their preventative behavior (i.e. increasing their physical activity--mean steps/day--at 1 and 3 months).
Findings will inform similar community-academic partnership efforts around stroke and other disease-specific prevention research/interventions; they will also determine next steps in terms of whether this case manager-centric model can be scaled up and deployed in other community-based settings.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
As many as 30% of ischemic strokes in the U.S. population can be attributed to physical inactivity.
With the goal of eliminating racial/ethnic stroke disparities, this interdisciplinary team proposes to develop, implement, and test a culturally-tailored behavioral intervention to reduce stroke risk (primary prevention) by increasing physical activity (walking) for 4 different racial/ethnic groups (Korean-Americans, Chinese-Americans, African-Americans and Latinos) in Los Angeles community senior centers.
The intervention combines stroke and stroke risk factor knowledge (using materials developed by the American Heart Association and American Stroke Association) with theoretically-grounded behavioral change techniques and focuses on reducing stroke risk by increasing physical activity (walking).
The study team will conduct focus groups (n=144) to identify culture-specific beliefs about stroke and stroke risk factors, to assess the feasibility and acceptability of the intervention, and will work with Community Action Panels to culturally-tailor the intervention.
The intervention will consist of 4 weeks of twice-weekly 1-hour group sessions implemented at 4 community senior centers by trained case managers who are part of the regular senior center staff and supported by congressionally-mandated Older Americans Act Title III funding.
The project team will test the effectiveness of the intervention in a randomized wait-list controlled trial (n=240) testing the hypothesis that the intervention will increase mean steps/day (measured by pedometer) at 1 and 3 months, and that the increase will be mediated by changes in stroke/stroke risk knowledge and self-efficacy.
Blood pressure will be examined as a secondary outcome.
In collaboration with the SPIRP Biomarker Collection & Analysis Core, the team will collect biological specimens (finger pricks) to explore the relationship between the intervention and biological markers of health; they will also explore the relationship between the intervention and healthcare seeking or taking medications to control stroke risk factors.
The team will evaluate the barriers and facilitators of successfully integrating the intervention into the senior centers in order to inform large-scale implementation of the culturally-tailored stroke risk factor reduction/walking intervention.
Tipo de estudio
Intervencionista
Inscripción (Actual)
240
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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California
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Los Angeles, California, Estados Unidos, 90012
- Chinatown Service Center
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Los Angeles, California, Estados Unidos, 90057
- St. Barnabas Senior Services
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Montebello, California, Estados Unidos, 90640
- Mexican American Opportunity Foundation
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Watts, California, Estados Unidos, 90059
- Watts Labor Community Action Committee
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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
60 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- age 60 years and older
- reported history of high blood pressure
Exclusion Criteria:
- younger than 60 years of age
- not self-identifying as the racial-ethnic group for the intervention planned at that site
- inability to communicate verbally in the appropriate language in a group setting (either due to lack of language skills, hearing impairment, or other disability)
- inability to sit in a chair and participate in a 1-hour discussion session
- inability to walk (the use of assistive devices such as canes and walkers is not an exclusion criterion)
- not available to attend the baseline data collection session and subsequent weekly intervention sessions
- plans to move away from the region during the next 6 months
- lacking cognitive capacity to provide informed consent to participate
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Walking Intervention
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4-week series of twice-weekly 1-hour group-based case-manager-led interactive sessions. The intervention will provide the knowledge necessary to improve stroke risk factors. Case manager group leaders will teach that seeing a healthcare provider regularly and monitoring blood pressure prevents strokes; all participants will be provided with the National Institute on Aging booklet, "How to Talk to your Doctor" and the contact information for their healthcare provider. Participants will be given a pedometer and be trained to use it to measure steps, with the goal of reaching 10,000 steps each day. The intervention will utilize attribution retraining to teach seniors that stroke risk factors including sedentary lifestyle should not be attributed to "old age." |
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Sin intervención: Wait-list control
After 3 months, participants will be invited to participate in the intervention.
No additional measures or outcomes will be recorded.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Mean steps/day at 3 months
Periodo de tiempo: 3 months
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Measured via pedometer.
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3 months
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Change from Baseline in Mean Steps/day at 1 month
Periodo de tiempo: 1 month
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Measured via pedometer.
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1 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Stroke and stroke risk factor knowledge
Periodo de tiempo: baseline, 1 month, and 3 months
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Stroke Action Survey (STAT)
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baseline, 1 month, and 3 months
|
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Self Efficacy
Periodo de tiempo: baseline, 1 month, and 3 months
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Chronic Disease Self Efficacy Scale and the Outcome Expectations Scale for Exercise
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baseline, 1 month, and 3 months
|
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Blood pressure
Periodo de tiempo: baseline, 1 month, and 3 months
|
baseline, 1 month, and 3 months
|
|
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BMI (kg/m^2)
Periodo de tiempo: baseline, 1 month, and 3 months
|
baseline, 1 month, and 3 months
|
|
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LDL cholesterol
Periodo de tiempo: baseline and 3 months
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Point-of-service CardioChek meter
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baseline and 3 months
|
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Glycosylated hemoglobin
Periodo de tiempo: baseline and 3 months
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Measured through finger prick.
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baseline and 3 months
|
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c-reactive protein
Periodo de tiempo: baseline and 3 months
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measured through finger prick
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baseline and 3 months
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Healthcare seeking
Periodo de tiempo: baseline and at 3 months
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Measure visits to a healthcare provider via survey.
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baseline and at 3 months
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Medications to control stroke risk factors
Periodo de tiempo: baseline and at 3 months
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Via survey, ask for names and doses of medications for hypertension, cholesterol, diabetes.
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baseline and at 3 months
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Socioeconomic status
Periodo de tiempo: baseline
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baseline
|
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Acculturation
Periodo de tiempo: Baseline
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Modified Marin Acculturation Scale
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Baseline
|
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Medical comorbidities
Periodo de tiempo: Baseline
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Katz/Charlson Comorbidity index
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Baseline
|
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Social support/network
Periodo de tiempo: Baseline, 1 month, 3 months
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Interpersonal Support Evaluation List (ISEL)
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Baseline, 1 month, 3 months
|
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Neighborhood Walkability
Periodo de tiempo: baseline
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Neighborhood Environment Walkability Scale (NEWS)
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baseline
|
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Health-related QOL
Periodo de tiempo: baseline, 1 month, and 3 months
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Medical outcomes study, Short Form (SF) 12
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baseline, 1 month, and 3 months
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Depressive symptoms
Periodo de tiempo: baseline, 1 month, and 3 months
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Patient Health Questionnaire
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baseline, 1 month, and 3 months
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Disability
Periodo de tiempo: baseline, 1 month, and 3 months
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Activities of Daily Living (ADL) Summary scale survey
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baseline, 1 month, and 3 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
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- Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW Jr, Bandura A, Gonzalez VM, Laurent DD, Holman HR. Chronic disease self-management program: 2-year health status and health care utilization outcomes. Med Care. 2001 Nov;39(11):1217-23. doi: 10.1097/00005650-200111000-00008.
- Qureshi AI, Mendelow AD, Hanley DF. Intracerebral haemorrhage. Lancet. 2009 May 9;373(9675):1632-44. doi: 10.1016/S0140-6736(09)60371-8.
- Chodosh J, Morton SC, Mojica W, Maglione M, Suttorp MJ, Hilton L, Rhodes S, Shekelle P. Meta-analysis: chronic disease self-management programs for older adults. Ann Intern Med. 2005 Sep 20;143(6):427-38. doi: 10.7326/0003-4819-143-6-200509200-00007.
- Tennstedt S, Howland J, Lachman M, Peterson E, Kasten L, Jette A. A randomized, controlled trial of a group intervention to reduce fear of falling and associated activity restriction in older adults. J Gerontol B Psychol Sci Soc Sci. 1998 Nov;53(6):P384-92. doi: 10.1093/geronb/53b.6.p384.
- Jones SP, Jenkinson AJ, Leathley MJ, Watkins CL. Stroke knowledge and awareness: an integrative review of the evidence. Age Ageing. 2010 Jan;39(1):11-22. doi: 10.1093/ageing/afp196. Epub 2009 Nov 6.
- Cruz-Flores S, Rabinstein A, Biller J, Elkind MS, Griffith P, Gorelick PB, Howard G, Leira EC, Morgenstern LB, Ovbiagele B, Peterson E, Rosamond W, Trimble B, Valderrama AL; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Epidemiology and Prevention; Council on Quality of Care and Outcomes Research. Racial-ethnic disparities in stroke care: the American experience: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011 Jul;42(7):2091-116. doi: 10.1161/STR.0b013e3182213e24. Epub 2011 May 26.
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- Morgenstern LB, Smith MA, Lisabeth LD, Risser JM, Uchino K, Garcia N, Longwell PJ, McFarling DA, Akuwumi O, Al-Wabil A, Al-Senani F, Brown DL, Moye LA. Excess stroke in Mexican Americans compared with non-Hispanic Whites: the Brain Attack Surveillance in Corpus Christi Project. Am J Epidemiol. 2004 Aug 15;160(4):376-83. doi: 10.1093/aje/kwh225.
- Hwang SY, Ryan CJ, Zerwic JJ. Korean immigrants' knowledge of heart attack symptoms and risk factors. J Immigr Minor Health. 2008 Feb;10(1):67-72. doi: 10.1007/s10903-007-9053-y.
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- O'Donnell MJ, Xavier D, Liu L, Zhang H, Chin SL, Rao-Melacini P, Rangarajan S, Islam S, Pais P, McQueen MJ, Mondo C, Damasceno A, Lopez-Jaramillo P, Hankey GJ, Dans AL, Yusoff K, Truelsen T, Diener HC, Sacco RL, Ryglewicz D, Czlonkowska A, Weimar C, Wang X, Yusuf S; INTERSTROKE investigators. Risk factors for ischaemic and intracerebral haemorrhagic stroke in 22 countries (the INTERSTROKE study): a case-control study. Lancet. 2010 Jul 10;376(9735):112-23. doi: 10.1016/S0140-6736(10)60834-3. Epub 2010 Jun 17.
- Sarkisian CA, Prohaska TR, Davis C, Weiner B. Pilot test of an attribution retraining intervention to raise walking levels in sedentary older adults. J Am Geriatr Soc. 2007 Nov;55(11):1842-6. doi: 10.1111/j.1532-5415.2007.01427.x.
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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
1 de octubre de 2014
Finalización primaria (Actual)
1 de agosto de 2016
Finalización del estudio (Actual)
1 de enero de 2018
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2014
Primero enviado que cumplió con los criterios de control de calidad
1 de julio de 2014
Publicado por primera vez (Estimar)
3 de julio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de diciembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
6 de diciembre de 2019
Última verificación
1 de diciembre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RFA-NS-12-007
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .