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Culturally Tailoring a Stroke Intervention in Community Senior Centers (SPIRP)

Primary Purpose

Hypertension, Stroke, Sedentary Lifestyle

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walking Intervention
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Stroke, Stroke prevention, older adults, self efficacy, walking, minorities, minority older adults, hypertension, high blood pressure, elderly, sedentary lifestyle

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinatown Service Center
  • St. Barnabas Senior Services
  • Mexican American Opportunity Foundation
  • Watts Labor Community Action Committee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Walking Intervention

Wait-list control

Arm Description

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."

After 3 months, participants will be invited to participate in the intervention. No additional measures or outcomes will be recorded.

Outcomes

Primary Outcome Measures

Change from Baseline in Mean steps/day at 3 months
Measured via pedometer.
Change from Baseline in Mean Steps/day at 1 month
Measured via pedometer.

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2014
Last Updated
December 6, 2019
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02181062
Brief Title
Culturally Tailoring a Stroke Intervention in Community Senior Centers
Acronym
SPIRP
Official Title
Implementing and Testing a Culturally-Tailored Stroke Risk Factor Reduction Intervention in Community Senior Centers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walking Intervention
Arm Type
Experimental
Arm Description
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."
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
After 3 months, participants will be invited to participate in the intervention. No additional measures or outcomes will be recorded.
Intervention Type
Behavioral
Intervention Name(s)
Walking Intervention
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline in Mean steps/day at 3 months
Description
Measured via pedometer.
Time Frame
3 months
Title
Change from Baseline in Mean Steps/day at 1 month
Description
Measured via pedometer.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Stroke and stroke risk factor knowledge
Description
Stroke Action Survey (STAT)
Time Frame
baseline, 1 month, and 3 months
Title
Self Efficacy
Description
Chronic Disease Self Efficacy Scale and the Outcome Expectations Scale for Exercise
Time Frame
baseline, 1 month, and 3 months
Title
Blood pressure
Time Frame
baseline, 1 month, and 3 months
Title
BMI (kg/m^2)
Time Frame
baseline, 1 month, and 3 months
Title
LDL cholesterol
Description
Point-of-service CardioChek meter
Time Frame
baseline and 3 months
Title
Glycosylated hemoglobin
Description
Measured through finger prick.
Time Frame
baseline and 3 months
Title
c-reactive protein
Description
measured through finger prick
Time Frame
baseline and 3 months
Title
Healthcare seeking
Description
Measure visits to a healthcare provider via survey.
Time Frame
baseline and at 3 months
Title
Medications to control stroke risk factors
Description
Via survey, ask for names and doses of medications for hypertension, cholesterol, diabetes.
Time Frame
baseline and at 3 months
Title
Socioeconomic status
Time Frame
baseline
Title
Acculturation
Description
Modified Marin Acculturation Scale
Time Frame
Baseline
Title
Medical comorbidities
Description
Katz/Charlson Comorbidity index
Time Frame
Baseline
Title
Social support/network
Description
Interpersonal Support Evaluation List (ISEL)
Time Frame
Baseline, 1 month, 3 months
Title
Neighborhood Walkability
Description
Neighborhood Environment Walkability Scale (NEWS)
Time Frame
baseline
Title
Health-related QOL
Description
Medical outcomes study, Short Form (SF) 12
Time Frame
baseline, 1 month, and 3 months
Title
Depressive symptoms
Description
Patient Health Questionnaire
Time Frame
baseline, 1 month, and 3 months
Title
Disability
Description
Activities of Daily Living (ADL) Summary scale survey
Time Frame
baseline, 1 month, and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine A Sarkisian, MD, MSPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinatown Service Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
Facility Name
St. Barnabas Senior Services
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Mexican American Opportunity Foundation
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Watts Labor Community Action Committee
City
Watts
State/Province
California
ZIP/Postal Code
90059
Country
United States

12. IPD Sharing Statement

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Culturally Tailoring a Stroke Intervention in Community Senior Centers

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