NCT02301299

Brief Summary

The investigators plan to develop and adapt a community-partnered intervention using community health promoters ("Stroke Promoters") to deliver messaging regarding stroke symptom awareness and the need for calling 911 after stroke onset. The study investigators will implement this intervention in south side Chicago communities and measure the impact on symptom onset to hospital arrival times and EMS utilization using an interrupted time-series analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
2 months until next milestone

Results Posted

Study results publicly available

September 9, 2019

Completed
Last Updated

September 9, 2019

Status Verified

July 1, 2019

Enrollment Period

3.6 years

First QC Date

November 21, 2014

Results QC Date

May 29, 2018

Last Update Submit

July 31, 2019

Conditions

Keywords

strokebarrierscommunity

Outcome Measures

Primary Outcomes (2)

  • Early Arrival After Stroke Onset

    Early hospital arrival was defined as the proportion of stroke patients arriving within three hours from symptom onset to intervention hospital. When symptom onset time was unknown or missing, last well-known time was used as symptom onset time. When both symptom onset time and last well-known time were unknown or missing, that admission was treated as late arrival.

    5 years; January 2013 to December 2017

  • Emergency Medical Services (EMS) Utilization for Stroke

    Emergency medical services (EMS) utilization (%) was defined as the proportion of stroke patients arriving to the emergency department by EMS, as opposed to private transport/taxi/other from home/scene. Admissions with Chicago Fire Department (CFD) record confirmed EMS arrival were considered as EMS arrival. All others were considered as non-EMS arrival. The effect size is measures a change in slope: percent of participants per month.

    5 years; January 2013 to December 2017

Secondary Outcomes (1)

  • Change in Knowledge and Self-efficacy

    12 months

Study Arms (1)

Community-based Stroke Awareness Program

Neighborhoods in the south side of Chicago surrounding a primary stroke center hospital will be targeted for a community-partnered stroke awareness and action educational campaign. To assess the effectiveness of this intervention, the investigators will monitor early hospital arrival and EMS use for stroke over a 60-month period comparing performance at the primary stroke center hospital using an interrupted time-series analysis.

Behavioral: Community-based Stroke Awareness Program

Interventions

A culturally-adapted stroke awareness and action program will be delivered by trained Stroke Promoters in the targeted neighborhoods in the south side of Chicago. Community Stroke Promoters will be trained on 1) the benefits of early recognition and EMS utilization for stroke (i.e. stroke centers, tPA), 2) culturally-adapted solutions to current barriers (i.e. misperceptions about vulnerability, severity, mistrust, costs), and 3) cues to aid in stroke recognition and immediate action. The intervention will take place at community settings throughout a 1-year period.

Also known as: Community Stroke Promoter Program
Community-based Stroke Awareness Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ischemic stroke patients arriving to the emergency department of a neighborhood primary stroke center in the south side of Chicago who are \> 18 years of age.

You may qualify if:

  • Adults 18 years of age or older
  • Hispanic, African American, or Caucasian/White
  • Reside within the following Chicago Zip Codes: 60617, 60619, 60620, 60621, 60628, 60629, 06032, 60639, or 60649

You may not qualify if:

  • \< 18 years old
  • Ethnic groups outside our targeted population
  • Outside targeted catchment area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Prabhakaran S, Richards CT, Kwon S, Wymore E, Song S, Eisenstein A, Brown J, Kandula NR, Mason M, Beckstrom H, Washington KV, Aggarwal NT. A Community-Engaged Stroke Preparedness Intervention in Chicago. J Am Heart Assoc. 2020 Sep 15;9(18):e016344. doi: 10.1161/JAHA.120.016344. Epub 2020 Sep 6.

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Erin Wymore
Organization
Northwestern University

Study Officials

  • Shyam Prabhakaran, MD MS

    Northwestern University

    PRINCIPAL INVESTIGATOR
  • Neelum T Aggarwal, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR
  • Knitasha Washington, DHA FACHE

    Washington Howard and Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

November 21, 2014

First Posted

November 25, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2018

Study Completion

June 30, 2019

Last Updated

September 9, 2019

Results First Posted

September 9, 2019

Record last verified: 2019-07

Locations