A Community Partnership to Treat Stroke
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ClinicalTrials.gov Identifier: NCT01499173 |
Recruitment Status :
Completed
First Posted : December 26, 2011
Results First Posted : September 29, 2017
Last Update Posted : September 29, 2017
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Condition or disease | Intervention/treatment | Phase |
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Stroke | Behavioral: Stroke Preparedness Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 101 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Community Partnership to Treat Stroke |
Study Start Date : | December 2014 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | September 2016 |

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.
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Behavioral: Stroke Preparedness Intervention
A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches. |
- Completion [ Time Frame: 1 week ]Number of participants who complete the intervention
- Mean Change in Behavioral Intent to Call 911 [ Time Frame: 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 [ Time Frame: 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 Social Norms Clustered Within Churches Across Multiple Time Points [ 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 ]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.
- Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points [ 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 ]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 [ 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 ]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.
- Program Satisfaction [ Time Frame: 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.

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Ages Eligible for Study: | 10 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499173
United States, Michigan | |
Flint, Michigan, United States, 48505 |
Principal Investigator: | Lesli Skolarus, MD | University of Michigan |
Responsible Party: | Lesli E. Skolarus, MD, Assistant Professor, University of Michigan |
ClinicalTrials.gov Identifier: | NCT01499173 |
Other Study ID Numbers: |
GRANT10624910 1K23NS073685-01 ( U.S. NIH Grant/Contract ) |
First Posted: | December 26, 2011 Key Record Dates |
Results First Posted: | September 29, 2017 |
Last Update Posted: | September 29, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |