NCT01499173

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Dec 2014

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

First Submitted

Initial submission to the registry

December 14, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
2.9 years until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 29, 2017

Completed
Last Updated

September 29, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

December 14, 2011

Results QC Date

December 15, 2016

Last Update Submit

August 4, 2017

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Completion

    Number of participants who complete the intervention

    1 week

Secondary Outcomes (5)

  • Mean Change in Behavioral Intent to Call 911

    1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop

  • Mean Change in Stroke Recognition

    1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop

  • Perception of Social Norms Clustered Within Churches Across Multiple Time Points

    1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test

  • Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points

    1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test

  • Perception of Stroke Attitude Clustered Within Churches Across Multiple Time Points

    1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test

Other Outcomes (1)

  • Program Satisfaction

    1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop

Study Arms (1)

Stroke preparedness intervention

EXPERIMENTAL

Youth and adults from predominately African American churches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design.

Behavioral: Stroke Preparedness Intervention

Interventions

Stroke Preparedness InterventionBEHAVIORAL

A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.

Stroke preparedness intervention

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Flint, Michigan, 48505, United States

Location

Related Publications (1)

  • Skolarus LE, Zimmerman MA, Bailey S, Dome M, Murphy JB, Kobrossi C, Dombrowski SU, Burke JF, Morgenstern LB. Stroke Ready Intervention: Community Engagement to Decrease Prehospital Delay. J Am Heart Assoc. 2016 May 20;5(5):e003331. doi: 10.1161/JAHA.116.003331.

    PMID: 27208000DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

Because this was a pre-post design, it cannot be the basis for a conclusion that Stroke Ready caused an increase in stroke preparedness and psychological variables

Results Point of Contact

Title
Dr. Lesli Skolarus
Organization
University of Michigan, Neurology
lerusche@umich.edu
734-936-9075

Study Officials

  • Lesli Skolarus, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 26, 2011

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Study Completion

September 1, 2016

Last Updated

September 29, 2017

Results First Posted

September 29, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)