Culturally Tailoring a Stroke Intervention in Community Senior Centers

Stroke Clinical Trial

— SPIRP  

Official title:

Implementing and Testing a Culturally-Tailored Stroke Risk Factor Reduction Intervention in Community Senior Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181062
• Other study ID #: RFA-NS-12-007
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: January 2018

Study information

• Verified date: December 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Hypertension
• Minority Groups
• Sedentary Lifestyle
• Stroke

Intervention

Behavioral:
• 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."

Locations

Country	Name	City	State
United States	Chinatown Service Center	Los Angeles	California
United States	St. Barnabas Senior Services	Los Angeles	California
United States	Mexican American Opportunity Foundation	Montebello	California
United States	Watts Labor Community Action Committee	Watts	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Mean steps/day at 3 months	Measured via pedometer.	3 months
Primary	Change from Baseline in Mean Steps/day at 1 month	Measured via pedometer.	1 month
Secondary	Stroke and stroke risk factor knowledge	Stroke Action Survey (STAT)	baseline, 1 month, and 3 months
Secondary	Self Efficacy	Chronic Disease Self Efficacy Scale and the Outcome Expectations Scale for Exercise	baseline, 1 month, and 3 months
Secondary	Blood pressure		baseline, 1 month, and 3 months
Secondary	BMI (kg/m^2)		baseline, 1 month, and 3 months
Secondary	LDL cholesterol	Point-of-service CardioChek meter	baseline and 3 months
Secondary	Glycosylated hemoglobin	Measured through finger prick.	baseline and 3 months
Secondary	c-reactive protein	measured through finger prick	baseline and 3 months
Secondary	Healthcare seeking	Measure visits to a healthcare provider via survey.	baseline and at 3 months
Secondary	Medications to control stroke risk factors	Via survey, ask for names and doses of medications for hypertension, cholesterol, diabetes.	baseline and at 3 months
Secondary	Socioeconomic status		baseline
Secondary	Acculturation	Modified Marin Acculturation Scale	Baseline
Secondary	Medical comorbidities	Katz/Charlson Comorbidity index	Baseline
Secondary	Social support/network	Interpersonal Support Evaluation List (ISEL)	Baseline, 1 month, 3 months
Secondary	Neighborhood Walkability	Neighborhood Environment Walkability Scale (NEWS)	baseline
Secondary	Health-related QOL	Medical outcomes study, Short Form (SF) 12	baseline, 1 month, and 3 months
Secondary	Depressive symptoms	Patient Health Questionnaire	baseline, 1 month, and 3 months
Secondary	Disability	Activities of Daily Living (ADL) Summary scale survey	baseline, 1 month, and 3 months