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Stroke Ready: A Stroke Preparedness Brief Intervention

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stroke preparedness intervention
Healthy lifestyle stroke risk reduction intervention
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring stroke preparedness, behavioral intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • over 18 years of age

Exclusion Criteria:

  • none

Sites / Locations

  • Hamilton Community Health Network
  • Hasselbring Senior Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stroke Preparedness Intervention

Healthy lifestyle intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Behavioral Intent to Call 911
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.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2019
Last Updated
December 1, 2019
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03831451
Brief Title
Stroke Ready: A Stroke Preparedness Brief Intervention
Official Title
Stroke Ready: A Stroke Preparedness Brief Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
April 23, 2019 (Actual)
Study Completion Date
April 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke preparedness, behavioral intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Subjects will be randomized to a brief face-to-face stroke preparedness intervention compared to a healthy lifestyle stroke risk reduction intervention. After completing the outcome assessment, subjects will have the opportunity to receive the intervention that they were not initially randomized too.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stroke Preparedness Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy lifestyle intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stroke preparedness intervention
Intervention Description
Face-to-face interaction with research staff lasting between 5-10 minutes
Intervention Type
Behavioral
Intervention Name(s)
Healthy lifestyle stroke risk reduction intervention
Intervention Description
Face-to-face interaction with research staff lasting between 5-10 minutes
Primary Outcome Measure Information:
Title
Change in Behavioral Intent to Call 911
Description
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.
Time Frame
Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: over 18 years of age Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesli Skolarus, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Community Health Network
City
Flint
State/Province
Michigan
ZIP/Postal Code
48505
Country
United States
Facility Name
Hasselbring Senior Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48505
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33238728
Citation
Robles MC, Springer MV, Corches CL, Burke JF, Lin CC, Oliver A, Skolarus LE. Stroke Ready Very Brief Intervention Improves Immediate Postintervention Stroke Preparedness. Circ Cardiovasc Qual Outcomes. 2020 Dec;13(12):e006643. doi: 10.1161/CIRCOUTCOMES.120.006643. Epub 2020 Nov 26. No abstract available.
Results Reference
derived

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Stroke Ready: A Stroke Preparedness Brief Intervention

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