Overview

This trial is active, not recruiting.

Condition stroke
Treatment stroke preparedness intervention
Phase phase 1
Sponsor University of Michigan
Collaborator National Institute of Neurological Disorders and Stroke (NINDS)
Start date December 2014
End date August 2015
Trial size 120 participants
Trial identifier NCT01499173, 1K23NS073685-01, GRANT10624910

Summary

Getting to the hospital quickly is the key to treating stroke. African Americans suffer more strokes with worse outcomes and receive stroke treatments less often than European Americans. This project will work to reduce these health disparities by creating and testing the feasibility of a peer-led faith-based behavioral intervention in an African American community with a goal to increase calls to 911 so stroke patients can be treated quickly.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.
stroke preparedness intervention
A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.

Primary Outcomes

Measure
Number of participate who complete the intervention
time frame: 6 weeks

Secondary Outcomes

Measure
Mean change in behavioral intent to call 911
time frame: 6 weeks
Mean change in stroke recognition
time frame: 6 weeks
Perception of self-efficacy
time frame: 6 weeks
Perception of social norms
time frame: 6 weeks
Perceived behavioral control
time frame: 6 weeks
Program satisfaction
time frame: 6 weeks

Eligibility Criteria

Male or female participants at least 10 years old.

Inclusion Criteria: To meet participant eligibility criteria, individuals must be 18 years of age or older (adult intervention) or between 10-17 years of age (youth intervention), a resident of the Flint or greater Flint community, and English speaking. Exclusion Criteria: We will attempt to exclude those who cannot read English because they will not be able to benefit from the intervention materials. These criteria will be confirmed during assessment procedures prior to enrollment.

Additional Information

Principal investigator Lesli Skolarus, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Michigan.