Culturally Tailoring a Stroke Intervention in Community Senior Centers (SPIRP)
6 декабря 2019 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
240
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
California
-
Los Angeles, California, Соединенные Штаты, 90012
- Chinatown Service Center
-
Los Angeles, California, Соединенные Штаты, 90057
- St. Barnabas Senior Services
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Montebello, California, Соединенные Штаты, 90640
- Mexican American Opportunity Foundation
-
Watts, California, Соединенные Штаты, 90059
- Watts Labor Community Action Committee
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
60 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Walking Intervention
|
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." |
|
Без вмешательства: Wait-list control
After 3 months, participants will be invited to participate in the intervention.
No additional measures or outcomes will be recorded.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change from Baseline in Mean steps/day at 3 months
Временное ограничение: 3 months
|
Measured via pedometer.
|
3 months
|
|
Change from Baseline in Mean Steps/day at 1 month
Временное ограничение: 1 month
|
Measured via pedometer.
|
1 month
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Stroke and stroke risk factor knowledge
Временное ограничение: baseline, 1 month, and 3 months
|
Stroke Action Survey (STAT)
|
baseline, 1 month, and 3 months
|
|
Self Efficacy
Временное ограничение: baseline, 1 month, and 3 months
|
Chronic Disease Self Efficacy Scale and the Outcome Expectations Scale for Exercise
|
baseline, 1 month, and 3 months
|
|
Blood pressure
Временное ограничение: baseline, 1 month, and 3 months
|
baseline, 1 month, and 3 months
|
|
|
BMI (kg/m^2)
Временное ограничение: baseline, 1 month, and 3 months
|
baseline, 1 month, and 3 months
|
|
|
LDL cholesterol
Временное ограничение: baseline and 3 months
|
Point-of-service CardioChek meter
|
baseline and 3 months
|
|
Glycosylated hemoglobin
Временное ограничение: baseline and 3 months
|
Measured through finger prick.
|
baseline and 3 months
|
|
c-reactive protein
Временное ограничение: baseline and 3 months
|
measured through finger prick
|
baseline and 3 months
|
|
Healthcare seeking
Временное ограничение: baseline and at 3 months
|
Measure visits to a healthcare provider via survey.
|
baseline and at 3 months
|
|
Medications to control stroke risk factors
Временное ограничение: baseline and at 3 months
|
Via survey, ask for names and doses of medications for hypertension, cholesterol, diabetes.
|
baseline and at 3 months
|
|
Socioeconomic status
Временное ограничение: baseline
|
baseline
|
|
|
Acculturation
Временное ограничение: Baseline
|
Modified Marin Acculturation Scale
|
Baseline
|
|
Medical comorbidities
Временное ограничение: Baseline
|
Katz/Charlson Comorbidity index
|
Baseline
|
|
Social support/network
Временное ограничение: Baseline, 1 month, 3 months
|
Interpersonal Support Evaluation List (ISEL)
|
Baseline, 1 month, 3 months
|
|
Neighborhood Walkability
Временное ограничение: baseline
|
Neighborhood Environment Walkability Scale (NEWS)
|
baseline
|
|
Health-related QOL
Временное ограничение: baseline, 1 month, and 3 months
|
Medical outcomes study, Short Form (SF) 12
|
baseline, 1 month, and 3 months
|
|
Depressive symptoms
Временное ограничение: baseline, 1 month, and 3 months
|
Patient Health Questionnaire
|
baseline, 1 month, and 3 months
|
|
Disability
Временное ограничение: baseline, 1 month, and 3 months
|
Activities of Daily Living (ADL) Summary scale survey
|
baseline, 1 month, and 3 months
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 октября 2014 г.
Первичное завершение (Действительный)
1 августа 2016 г.
Завершение исследования (Действительный)
1 января 2018 г.
Даты регистрации исследования
Первый отправленный
30 июня 2014 г.
Впервые представлено, что соответствует критериям контроля качества
1 июля 2014 г.
Первый опубликованный (Оценивать)
3 июля 2014 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
9 декабря 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
6 декабря 2019 г.
Последняя проверка
1 декабря 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- RFA-NS-12-007
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .