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Stroke Ready: A Stroke Preparedness Brief Intervention

NCT ID: NCT03831451

Last Updated: 2019-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-04

Study Completion Date

2019-04-23

Brief Summary

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

Detailed Description

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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

Conditions

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Stroke

Keywords

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stroke preparedness behavioral intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Stroke preparedness intervention

Intervention Type BEHAVIORAL

Face-to-face interaction with research staff lasting between 5-10 minutes

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.

Group Type ACTIVE_COMPARATOR

Healthy lifestyle stroke risk reduction intervention

Intervention Type BEHAVIORAL

Face-to-face interaction with research staff lasting between 5-10 minutes

Interventions

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Stroke preparedness intervention

Face-to-face interaction with research staff lasting between 5-10 minutes

Intervention Type BEHAVIORAL

Healthy lifestyle stroke risk reduction intervention

Face-to-face interaction with research staff lasting between 5-10 minutes

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* over 18 years of age

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Lesli E. Skolarus, MD

Associate Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lesli Skolarus, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Hamilton Community Health Network

Flint, Michigan, United States

Site Status

Hasselbring Senior Center

Flint, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33238728 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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U01MD010579

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01MD010579-substudy

Identifier Type: -

Identifier Source: org_study_id