A Community Partnership to Treat Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Stroke Preparedness Intervention

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48505

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stroke preparedness intervention; 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; A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion	Number of participants who complete the intervention	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Behavioral Intent to Call 911	The pre-test is conducted one week prior to the post-test. A higher score indicates greater behavioral intent. Behavioral intent is measured on a scale of 0 - 8, where 0 indicates no correct answers in responses to scenarios, and 8 indicates appropriate responses (calling 911 every time it is appropriate) to the scenarios presented.	1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop
Mean Change in Stroke Recognition	Stroke recognition was scored on a 0 - 9 point scale where 0 represents no correct answers regarding 9 scenarios and 9 represents perfect 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	Perception of social norms is measured by the odds ratio of the responses to questions of participant agreement with others' influence to calling 911 if he/she were to see a stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of the positive change in social norms in the post-test compared to the pre-test. Questions: 1) Most people would call 911 if they were to see a stroke. 2) My family would want me to call 911 if I were to see a stroke. Given that participants within each church are more alike than participants between churches and the multiple time points, hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed post-test social norms after accounting for the participants' church.	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	Perception of self-efficacy is measured by the odds ratios of the responses to questions of participant confidence in being able to identify and respond appropriately to a stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of positive self-efficacy change in the post-test compared to the pretest. Questions asking about self-efficacy were:1) I would be able to tell if someone is having a stroke and 2) I know what to do if I saw someone having a stroke. Given that participants within each church are more alike than participants between churches and multiple time points hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed posttest self-efficacy after accounting for the participants' church.	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	Stroke attitude is measured by the odds ratio of participant's positive perception of calling 911 for stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of stroke attitude change in the post-test compared to pre-test. Stroke attitude questioners were: Q1) If I were to see signs of a stroke, calling 911 would be... (range "extremely pleasant" to "very unpleasant); and Q2) If a person has signs of a stroke, calling 911 right away could be... (range "very helpful" to "very harmful). Given that participants within each church are more alike than participants between churches and multiple time points, hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed post-test stroke attitude after accounting for the participants' church.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program Satisfaction	Program satisfaction is measured by percentage of participants that completed the program who answered on the post test: very satisfied or extremely satisfied on a questionnaire about the program.	1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 14, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: August 4, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: GRANT10624910; 1K23NS073685-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No