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Completed

NCT Number: NCT02181062

Culturally Tailoring a Stroke 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinatown Service Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking Intervention

Behavioral

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."

Primary outcomes

  1. Change from Baseline in Mean steps/day at 3 months

    Time frame: 3 months

    Measured via pedometer.

  2. Change from Baseline in Mean Steps/day at 1 month

    Time frame: 1 month

    Measured via pedometer.

Secondary outcomes

  1. Stroke and stroke risk factor knowledge

    Time frame: baseline, 1 month, and 3 months

    Stroke Action Survey (STAT)

  2. Self Efficacy

    Time frame: baseline, 1 month, and 3 months

    Chronic Disease Self Efficacy Scale and the Outcome Expectations Scale for Exercise

  3. Blood pressure

    Time frame: baseline, 1 month, and 3 months

  4. BMI (kg/m^2)

    Time frame: baseline, 1 month, and 3 months

  5. LDL cholesterol

    Time frame: baseline and 3 months

    Point-of-service CardioChek meter

  6. Glycosylated hemoglobin

    Time frame: baseline and 3 months

    Measured through finger prick.

  7. c-reactive protein

    Time frame: baseline and 3 months

    measured through finger prick

  8. Healthcare seeking

    Time frame: baseline and at 3 months

    Measure visits to a healthcare provider via survey.

  9. Medications to control stroke risk factors

    Time frame: baseline and at 3 months

    Via survey, ask for names and doses of medications for hypertension, cholesterol, diabetes.

  10. Socioeconomic status

    Time frame: baseline

  11. Acculturation

    Time frame: Baseline

    Modified Marin Acculturation Scale

  12. Medical comorbidities

    Time frame: Baseline

    Katz/Charlson Comorbidity index

  13. Social support/network

    Time frame: Baseline, 1 month, 3 months

    Interpersonal Support Evaluation List (ISEL)

  14. Neighborhood Walkability

    Time frame: baseline

    Neighborhood Environment Walkability Scale (NEWS)

  15. Health-related QOL

    Time frame: baseline, 1 month, and 3 months

    Medical outcomes study, Short Form (SF) 12

  16. Depressive symptoms

    Time frame: baseline, 1 month, and 3 months

    Patient Health Questionnaire

  17. Disability

    Time frame: baseline, 1 month, and 3 months

    Activities of Daily Living (ADL) Summary scale survey

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Acronym: SPIRP

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jul 3, 2014
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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