Clinical trial NCT02181062: Culturally Tailoring a Stroke Intervention in Community Senior Centers
Official title: Implementing and Testing a Culturally-Tailored Stroke Risk Factor Reduction Intervention in Community Senior Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Stroke
Sedentary Lifestyle
Aged
Minority Groups
Keywords: Stroke
Stroke prevention
older adults
self efficacy
walking
minorities
minority older adults
hypertension
high blood pressure
elderly
sedentary lifestyle
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 240
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Mean steps/day at 3 months
timeFrame: 3 months
measure: Change from Baseline in Mean Steps/day at 1 month
timeFrame: 1 month
Secondary outcomes:
measure: Stroke and stroke risk factor knowledge
timeFrame: baseline, 1 month, and 3 months
measure: Self Efficacy
timeFrame: baseline, 1 month, and 3 months
measure: Blood pressure
timeFrame: baseline, 1 month, and 3 months
measure: BMI (kg/m^2)
timeFrame: baseline, 1 month, and 3 months
measure: LDL cholesterol
timeFrame: baseline and 3 months
measure: Glycosylated hemoglobin
timeFrame: baseline and 3 months
measure: c-reactive protein
timeFrame: baseline and 3 months
measure: Healthcare seeking
timeFrame: baseline and at 3 months
measure: Medications to control stroke risk factors
timeFrame: baseline and at 3 months
measure: Socioeconomic status
timeFrame: baseline
measure: Acculturation
timeFrame: Baseline
measure: Medical comorbidities
timeFrame: Baseline
measure: Social support/network
timeFrame: Baseline, 1 month, 3 months
measure: Neighborhood Walkability
timeFrame: baseline
measure: Health-related QOL
timeFrame: baseline, 1 month, and 3 months
measure: Depressive symptoms
timeFrame: baseline, 1 month, and 3 months
measure: Disability
timeFrame: baseline, 1 month, and 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Chinatown Service Center
state: California
city: Los Angeles
country: United States
facility: St. Barnabas Senior Services
state: California
city: Montebello
country: United States
facility: Mexican American Opportunity Foundation
state: California
city: Watts
country: United States
facility: Watts Labor Community Action Committee
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Catherine A Sarkisian, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
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