NCT03831451

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 20, 2019

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

January 24, 2019

Results QC Date

September 4, 2019

Last Update Submit

December 1, 2019

Conditions

Stroke

Keywords

stroke preparednessbehavioral intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention

Study Arms (2)

Stroke Preparedness Intervention

EXPERIMENTAL

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

Healthy lifestyle intervention

ACTIVE COMPARATOR

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

Interventions

Stroke preparedness interventionBEHAVIORAL

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

Stroke Preparedness Intervention
Healthy lifestyle stroke risk reduction interventionBEHAVIORAL

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

Healthy lifestyle intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years of age

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hamilton Community Health Network

Flint, Michigan, 48505, United States

Location

Hasselbring Senior Center

Flint, Michigan, 48505, United States

Location

Related Publications (1)

  • 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.

    PMID: 33238728DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Lesli Skolarus
Organization
University of Michigan
lerusche@umich.edu
734-936-9075

Study Officials

  • Lesli Skolarus, MD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

January 24, 2019

First Posted

February 5, 2019

Study Start

March 4, 2019

Primary Completion

April 23, 2019

Study Completion

April 23, 2019

Last Updated

December 13, 2019

Results First Posted

November 20, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)