Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stroke Ready - Optimizing Acute Stroke Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645590
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : September 28, 2020
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Lesli E. Skolarus, MD, University of Michigan

Brief Summary:
The study aims to increase acute stroke treatment rates in Flint, Michigan through a two-pronged approach of hospital and community level interventions. It also aims to inform future stroke preparedness interventions by exploring the relative importance of hospital optimization and community interventions.

Condition or disease Intervention/treatment Phase
Stroke, Acute Stroke Behavioral: Stroke Ready Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Stroke Ready is a stepped wedge design to be delivered to each of the four Flint community quadrants over the course of 2 years.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Stroke Ready - Optimizing Acute Stroke Care
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: Stroke Ready Community intervention
We divided the Flint community into four quadrants. We will focus our workshops and posters on one quadrant, but not exclusively, moving quadrants every 6 months over the course of two years.
Behavioral: Stroke Ready
Stroke Ready community intervention consists of peer facilitated educational workshops, stroke music video, and mass media campaign including print materials (e.g. posters, brochure), health promotion mailers, radio/Television public health service announcements, and the Stroke Ready website and Facebook page.




Primary Outcome Measures :
  1. Acute stroke treatment rate (tPA and endovascular treatment) [ Time Frame: Time frame: 11 years of data will be reviewed ]
    Acute stroke treatment rate - community wide. Retrospective data captured through medical record review


Secondary Outcome Measures :
  1. Number of emergency department arrivals by ambulance [ Time Frame: Time frame: 11 years of data will be reviewed ]
    Optimize community for acute stroke (community level)--retrospective data captured through medical record review

  2. Acute stroke treatment rate (tPA treatment) [ Time Frame: Time frame: 11 years of data will be reviewed ]
    Acute stroke treatment rate - community wide. Retrospective data captured through medical record review



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Inclusion criteria:Adult stroke patients who presented to one of three hospitals in the Flint community.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645590


Contacts
Layout table for location contacts
Contact: Lesli Skolarus, MD 734-936-9075 lerusche@umich.edu

Locations
Layout table for location information
United States, Michigan
Flint Communiy Recruiting
Flint, Michigan, United States, 48502
Contact: Casey Corches    734-936-9075      
Sponsors and Collaborators
University of Michigan
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Layout table for investigator information
Principal Investigator: Lesli Skolarus, MD University of Michigan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Lesli E. Skolarus, MD, Associate Professor of Neurology, University of Michigan
ClinicalTrials.gov Identifier: NCT03645590    
Other Study ID Numbers: U01MD010579 ( U.S. NIH Grant/Contract )
U01MD010579 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases