NCT02181062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable hypertension

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

1.8 years

First QC Date

June 30, 2014

Last Update Submit

December 6, 2019

Conditions

Keywords

StrokeStroke preventionolder adultsself efficacywalkingminoritiesminority older adultshypertensionhigh blood pressureelderlysedentary lifestyle

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Mean steps/day at 3 months

    Measured via pedometer.

    3 months

  • Change from Baseline in Mean Steps/day at 1 month

    Measured via pedometer.

    1 month

Secondary Outcomes (17)

  • Stroke and stroke risk factor knowledge

    baseline, 1 month, and 3 months

  • Self Efficacy

    baseline, 1 month, and 3 months

  • Blood pressure

    baseline, 1 month, and 3 months

  • BMI (kg/m^2)

    baseline, 1 month, and 3 months

  • LDL cholesterol

    baseline and 3 months

  • +12 more secondary outcomes

Study Arms (2)

Walking Intervention

EXPERIMENTAL

1. 4-week series of twice-weekly 1-hour group-based case-manager-led interactive sessions. 2. 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. 3. 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. 4. The intervention will utilize attribution retraining to teach seniors that stroke risk factors including sedentary lifestyle should not be attributed to "old age."

Behavioral: Walking Intervention

Wait-list control

NO INTERVENTION

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

Interventions

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."

Walking Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 60 years and older
  • reported history of high blood pressure

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chinatown Service Center

Los Angeles, California, 90012, United States

Location

St. Barnabas Senior Services

Los Angeles, California, 90057, United States

Location

Mexican American Opportunity Foundation

Montebello, California, 90640, United States

Location

Watts Labor Community Action Committee

Watts, California, 90059, United States

Location

Related Publications (24)

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    PMID: 15286023BACKGROUND
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    PMID: 18086926BACKGROUND
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    PMID: 19427958BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
  • Menkin JA, McCreath HE, Song SY, Carrillo CA, Reyes CE, Trejo L, Choi SE, Willis P, Jimenez E, Ma S, Chang E, Liu H, Kwon I, Kotick J, Sarkisian CA. "Worth the Walk": Culturally Tailored Stroke Risk Factor Reduction Intervention in Community Senior Centers. J Am Heart Assoc. 2019 Mar 19;8(6):e011088. doi: 10.1161/JAHA.118.011088.

  • Kwon I, Choi S, Mittman B, Bharmal N, Liu H, Vickrey B, Song S, Araiza D, McCreath H, Seeman T, Oh SM, Trejo L, Sarkisian C. Study protocol of "Worth the Walk": a randomized controlled trial of a stroke risk reduction walking intervention among racial/ethnic minority older adults with hypertension in community senior centers. BMC Neurol. 2015 Jun 15;15:91. doi: 10.1186/s12883-015-0346-9.

MeSH Terms

Conditions

HypertensionStrokeSedentary Behavior

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • Catherine A Sarkisian, MD, MSPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, L.A. CAPRA Center

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 3, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2016

Study Completion

January 1, 2018

Last Updated

December 9, 2019

Record last verified: 2019-12

Locations