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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23NS073685-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stroke Preparedness Intervention | Behavioral | A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion | Number of participants who complete the intervention | 1 week |
| 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 |
| 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 |
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.
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| Name | Affiliation | Role |
|---|---|---|
| Lesli Skolarus, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flint | Michigan | 48505 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27208000 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stroke Preparedness Intervention | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stroke Preparedness Intervention | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | we present the age of the youth and adults separately |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Completion | Number of participants who complete the intervention | descriptive | Posted | Count of Participants | Participants | 1 week |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stroke Preparedness Intervention | 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. |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lesli Skolarus | University of Michigan, Neurology | 734-936-9075 | lerusche@umich.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| Median |
| Inter-Quartile Range |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop |
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| Secondary | 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. | Posted | Number | odds ratio | 1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test |
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| Secondary | 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. | Posted | Number | odds ratio | 1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test |
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| Secondary | 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. | Posted | Number | Odds ratio | 1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test |
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| Other Pre-specified | 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. | Posted | Number | percentage of participants | 1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
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| 1 mo: Q2: My family would want me to call 911 |
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| Title | Measurements |
|---|---|
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| 1 mo: Q2: I know what to do |
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| Title | Measurements |
|---|---|
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| 1 mo: Q2: If a person has signs of a stroke... |
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