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A Community Partnership to Treat Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01499173
First Posted: December 26, 2011
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Lesli E. Skolarus, MD, University of Michigan
  Purpose
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.

Condition Intervention
Stroke Behavioral: Stroke Preparedness Intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Community Partnership to Treat Stroke

Resource links provided by NLM:


Further study details as provided by Lesli E. Skolarus, MD, University of Michigan:

Primary Outcome Measures:
  • Completion [ Time Frame: 1 week ]
    Number of participants who complete the intervention


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 101
Study Start Date: December 2014
Study Completion Date: September 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Michigan
Flint, Michigan, United States, 48505
Sponsors and Collaborators
University of Michigan
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Lesli Skolarus, MD University of Michigan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lesli E. Skolarus, MD, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01499173     History of Changes
Other Study ID Numbers: GRANT10624910
1K23NS073685-01 ( U.S. NIH Grant/Contract )
First Submitted: December 14, 2011
First Posted: December 26, 2011
Results First Submitted: December 15, 2016
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

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases