Tailored Approaches to Stroke Health Education
TASHE
2 other identifiers
interventional
290
1 country
2
Brief Summary
The overarching goal of the proposed intervention is to reduce stroke disparities by overcoming pre-hospital barriers related to emergency stroke treatment and facilitating the appropriate response to acute stroke using a novel culturally-tailored and sustainable approach developed by an experienced transdisciplinary team. Building on our previous work, in which the investigators have identified barriers to increasing stroke literacy and behavioral intent to call 911, the investigators will develop and evaluate the effectiveness of a novel, culturally tailored intervention using storytelling (narrative persuasion) in the form of two professionally produced 12-minute films (in English and Spanish), in minority populations in New York City (NYC). Behavioral intent to call 911 will be assessed immediately after viewing the film, 6 months later, and one year later.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Apr 2014
Longer than P75 for not_applicable stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2013
CompletedFirst Posted
Study publicly available on registry
July 26, 2013
CompletedStudy Start
First participant enrolled
April 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 15, 2020
July 1, 2020
3.1 years
July 22, 2013
July 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score on Stroke Action Test
The Stroke Action Test (STAT) contains 21 items that name or describe stroke symptoms from all 5 groups of warning signs and 7 items that are nonstroke symptoms. For each item, the respondent selects 1 of 4 options: call 911, call doctor, wait 1 hour, or wait 1 day. For scoring purposes, each correct response receives 1 point; incorrect responses receive 0 points. The total score is reported as percent of correct responses. Scores range from 0% to 100% with a higher score indicating a better outcome.
Within one hour of stroke education intervention.
Secondary Outcomes (2)
Score on Stroke Action Test
Within six months of stroke education intervention.
Score on Stroke Action Test
Within one year of stroke education intervention.
Other Outcomes (1)
Time to emergency room after suffering a stroke
Up to 3.5 years post-intervention
Study Arms (2)
Intervention Group
EXPERIMENTALParticipants will receive education through a novel program called Stroke Education Film Viewing.
Usual Care Group
OTHERParticipants will receive education through Stroke Education Pamphlet Exposure.
Interventions
A novel, culturally tailored intervention using storytelling (narrative persuasion) in the form of two professionally produced 12-min films (in English and Spanish), in minority populations in New York City.
"Usual Care": Stroke Education pamphlet and brochure distribution.
Eligibility Criteria
You may qualify if:
- No prior history of stroke;
- High risk (defined as a history of one or more stroke risk factor (hypertension (HTN), diabetes, tobacco, abdominal obesity, heart disease, high cholesterol);
- Over age 34 years at onset of intervention (we have selected this age cut off due to the large increase in stroke incidence among minority groups at age 34 );
- Self-identified as Black or Hispanic; and
- Member of a church congregation who lives in a household with a telephone.
You may not qualify if:
- Participant is unable to give consent;
- A modified Rankin score \> 4 at baseline;
- history of dementia; and
- terminal illness, or other medical illness resulting in mortality \< 1 year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Columbia University Medical Center, Neurological Institute
New York, New York, 10032, United States
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (2)
Williams O, Teresi J, Eimicke JP, Abel-Bey A, Hassankhani M, Valdez L, Gomez Chan L, Kong J, Ramirez M, Ravenell J, Ogedegbe G, Noble JM. Effect of Stroke Education Pamphlets vs a 12-Minute Culturally Tailored Stroke Film on Stroke Preparedness Among Black and Hispanic Churchgoers: A Cluster Randomized Clinical Trial. JAMA Neurol. 2019 Oct 1;76(10):1211-1218. doi: 10.1001/jamaneurol.2019.1741.
PMID: 31260028DERIVEDRavenell J, Leighton-Herrmann E, Abel-Bey A, DeSorbo A, Teresi J, Valdez L, Gordillo M, Gerin W, Hecht M, Ramirez M, Noble J, Cohn E, Jean-Louis G, Spruill T, Waddy S, Ogedegbe G, Williams O. Tailored approaches to stroke health education (TASHE): study protocol for a randomized controlled trial. Trials. 2015 Apr 19;16:176. doi: 10.1186/s13063-015-0703-4.
PMID: 25927452DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olajide. A Williams, MD, MS
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Staff of Neurology Associate Professor of Clinical Neurology
Study Record Dates
First Submitted
July 22, 2013
First Posted
July 26, 2013
Study Start
April 16, 2014
Primary Completion
June 8, 2017
Study Completion
December 1, 2019
Last Updated
July 15, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share