Culturally Tailoring a Stroke Intervention in Community Senior Centers (SPIRP)
6 de dezembro de 2019 atualizado 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
240
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
60 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in Mean steps/day at 3 months
Prazo: 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
Prazo: 1 month
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Measured via pedometer.
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1 month
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Stroke and stroke risk factor knowledge
Prazo: 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
Prazo: 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
Prazo: baseline, 1 month, and 3 months
|
baseline, 1 month, and 3 months
|
|
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BMI (kg/m^2)
Prazo: baseline, 1 month, and 3 months
|
baseline, 1 month, and 3 months
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|
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LDL cholesterol
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: baseline
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baseline
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Acculturation
Prazo: Baseline
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Modified Marin Acculturation Scale
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Baseline
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Medical comorbidities
Prazo: Baseline
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Katz/Charlson Comorbidity index
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Baseline
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Social support/network
Prazo: 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
Prazo: baseline
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Neighborhood Environment Walkability Scale (NEWS)
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baseline
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Health-related QOL
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Publicações Gerais
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de outubro de 2014
Conclusão Primária (Real)
1 de agosto de 2016
Conclusão do estudo (Real)
1 de janeiro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
30 de junho de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de julho de 2014
Primeira postagem (Estimativa)
3 de julho de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de dezembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de dezembro de 2019
Última verificação
1 de dezembro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RFA-NS-12-007
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .