Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Community Partnership to Treat Stroke

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Lesli E. Skolarus, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01499173
First received: December 14, 2011
Last updated: October 6, 2015
Last verified: October 2015
  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 Phase
Stroke
Behavioral: Stroke Preparedness Intervention
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Number of participate who complete the intervention [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in behavioral intent to call 911 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Mean change in stroke recognition [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Perception of self-efficacy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Perception of social norms [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Perceived behavioral control [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Program satisfaction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2014
Estimated Study Completion Date: August 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 chruches 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

Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 
Study First Received: December 14, 2011
Last Updated: October 6, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016