Culturally Tailoring a Stroke Intervention in Community Senior Centers (SPIRP)
2019年12月6日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
240
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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California
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Los Angeles、California、アメリカ、90012
- Chinatown Service Center
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Los Angeles、California、アメリカ、90057
- St. Barnabas Senior Services
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Montebello、California、アメリカ、90640
- Mexican American Opportunity Foundation
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Watts、California、アメリカ、90059
- Watts Labor Community Action Committee
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
60年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in Mean steps/day at 3 months
時間枠：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
時間枠：1 month
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Measured via pedometer.
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1 month
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Stroke and stroke risk factor knowledge
時間枠：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
時間枠：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
時間枠：baseline, 1 month, and 3 months
|
baseline, 1 month, and 3 months
|
|
|
BMI (kg/m^2)
時間枠：baseline, 1 month, and 3 months
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baseline, 1 month, and 3 months
|
|
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LDL cholesterol
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：baseline
|
baseline
|
|
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Acculturation
時間枠：Baseline
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Modified Marin Acculturation Scale
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Baseline
|
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Medical comorbidities
時間枠：Baseline
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Katz/Charlson Comorbidity index
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Baseline
|
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Social support/network
時間枠：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
時間枠：baseline
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Neighborhood Environment Walkability Scale (NEWS)
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baseline
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Health-related QOL
時間枠：baseline, 1 month, and 3 months
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Medical outcomes study, Short Form (SF) 12
|
baseline, 1 month, and 3 months
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Depressive symptoms
時間枠：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
時間枠：baseline, 1 month, and 3 months
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Activities of Daily Living (ADL) Summary scale survey
|
baseline, 1 month, and 3 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年10月1日
一次修了 (実際)
2016年8月1日
研究の完了 (実際)
2018年1月1日
試験登録日
最初に提出
2014年6月30日
QC基準を満たした最初の提出物
2014年7月1日
最初の投稿 (見積もり)
2014年7月3日
学習記録の更新
投稿された最後の更新 (実際)
2019年12月9日
QC基準を満たした最後の更新が送信されました
2019年12月6日
最終確認日
2019年12月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。