Stroke Ready: A Stroke Preparedness Brief Intervention

December 1, 2019 updated by: Lesli E. Skolarus, MD, University of Michigan
This is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness. Subjects will be randomized to a brief face-to-face stroke preparedness intervention compared to a healthy lifestyle stroke risk reduction intervention. The primary outcome is behavioral intent to call 911 using a self-administered survey

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Flint, Michigan, United States, 48505
        • Hamilton Community Health Network
      • Flint, Michigan, United States, 48505
        • Hasselbring Senior Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • over 18 years of age

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stroke Preparedness Intervention
The stroke preparedness educational intervention was designed with input from the community where it is being tested. It will be delivered in-person by a research team member. The intervention focuses on recognizing stroke symptoms and the importance of calling 911.
Behavioral: Stroke preparedness intervention
Face-to-face interaction with research staff lasting between 5-10 minutes
Active Comparator: Healthy lifestyle intervention
The Healthy lifestyle stroke risk reduction educational intervention is based on patient materials from the American Heart Association. It will be delivered in-person by a research team member. The intervention focuses on stroke risk reduction.
Behavioral: Healthy lifestyle stroke risk reduction intervention
Face-to-face interaction with research staff lasting between 5-10 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Behavioral Intent to Call 911
Time Frame: Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention
Change in Behavioral intent to call 911 using a self-administered survey. The survey is the Stroke Action test which was modified based on community input. Scores range from 0-12 for stroke. A higher score means greater stroke behavioral intent to call 911 for a stroke while a low score means lower behavioral intent to call 911 for a stroke.
Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Lesli Skolarus, MD, MS, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2019

Primary Completion (Actual)

April 23, 2019

Study Completion (Actual)

April 23, 2019

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

February 3, 2019

First Posted (Actual)

February 5, 2019

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 1, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01MD010579-substudy
  • U01MD010579 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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