Stroke
Conditions
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.
Interventions
BEHAVIORALStroke Preparedness Intervention
A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion | 1 week | Number of participants who complete the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Mean Change in Stroke Recognition | 1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop | 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. |
| 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 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. |
| 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 | 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. |
| 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Program Satisfaction | 1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Stroke Preparedness Intervention |
|---|---|
| Age, Continuous adults | 56 years |
| Age, Continuous youth | 14 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 101 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 101 Participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 101 |
| serious Total, serious adverse events | 0 / 101 |
Outcome results
Primary
Completion
Number of participants who complete the intervention
Time frame: 1 week
Population: descriptive
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stroke Preparedness Intervention | Completion | 64 Participants |
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.
Time frame: 1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stroke Preparedness Intervention | Mean Change in Behavioral Intent to Call 911 | pre-test | 4.4 units on a scale |
| Stroke Preparedness Intervention | Mean Change in Behavioral Intent to Call 911 | post-test | 5.2 units on a scale |
p-value: <0.01multilevel linear regression
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.
Time frame: 1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stroke Preparedness Intervention | Mean Change in Stroke Recognition | pre-test | 5.9 units on a scale |
| Stroke Preparedness Intervention | Mean Change in Stroke Recognition | post-test | 6.0 units on a scale |
p-value: 0.34multilevel linear regression
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.
Time frame: 1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stroke Preparedness Intervention | Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points | 1 wk: Q 1: I'd be able to tell | 1.2 odds ratio |
| Stroke Preparedness Intervention | Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points | 1 wk: Q2: I know what to do | .8 odds ratio |
| Stroke Preparedness Intervention | Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points | 1 mo. Q 1: I'd be able to tell | .8 odds ratio |
| Stroke Preparedness Intervention | Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points | 1 mo: Q2: I know what to do | .3 odds ratio |
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.
Time frame: 1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stroke Preparedness Intervention | Perception of Social Norms Clustered Within Churches Across Multiple Time Points | 1 mo: Q2: My family would want me to call 911 | 0.1 odds ratio |
| Stroke Preparedness Intervention | Perception of Social Norms Clustered Within Churches Across Multiple Time Points | 1 wk: Q1: Most people would call 911 | -0.5 odds ratio |
| Stroke Preparedness Intervention | Perception of Social Norms Clustered Within Churches Across Multiple Time Points | 1 wk: Q2: My family would want me to call 911 | 0.2 odds ratio |
| Stroke Preparedness Intervention | Perception of Social Norms Clustered Within Churches Across Multiple Time Points | 1 mo: Q1: Most people would call 911 | -0.9 odds ratio |
Comparison: Odds ratio was calculated for each question comparing 1 week data with 1 month data
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.
Time frame: 1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stroke Preparedness Intervention | Perception of Stroke Attitude Clustered Within Churches Across Multiple Time Points | 1 wk: Q1: If I were to see... | .05 Odds ratio |
| Stroke Preparedness Intervention | Perception of Stroke Attitude Clustered Within Churches Across Multiple Time Points | 1 wk: Q2: If a person has signs of a stroke... | 0.3 Odds ratio |
| Stroke Preparedness Intervention | Perception of Stroke Attitude Clustered Within Churches Across Multiple Time Points | 1 mo: Q1: If I were to see... | -0.07 Odds ratio |
| Stroke Preparedness Intervention | Perception of Stroke Attitude Clustered Within Churches Across Multiple Time Points | 1 mo: Q2: If a person has signs of a stroke... | -0.5 Odds ratio |
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.
Time frame: 1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stroke Preparedness Intervention | Program Satisfaction | 80 percentage of participants |