Tailored Approaches to Stroke Health Education (TASHE)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stroke Education Film Viewing
Stroke Education Pamphlet Exposure
Sponsored by

About this trial
This is an interventional prevention trial for Stroke focused on measuring Stroke, Community Health Education, Minority Health, healthcare disparities
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Columbia University Medical Center, Neurological Institute
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention Group
Usual Care Group
Arm Description
Participants will receive education through a novel program called Stroke Education Film Viewing.
Participants will receive education through Stroke Education Pamphlet Exposure.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01909271
First Posted
July 22, 2013
Last Updated
July 13, 2020
Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT01909271
Brief Title
Tailored Approaches to Stroke Health Education
Acronym
TASHE
Official Title
Tailored Approaches to Stroke Health Education
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 16, 2014 (Actual)
Primary Completion Date
June 8, 2017 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Stroke is the leading cause of adult disability and costs U.S. taxpayers >$60 billion annually. Interventions designed to educate patients to seek treatment sooner when a stroke occurs may increase low rates of treatment with thrombolysis (current rates 3% national average). Thrombolysis can increase the odds of minimal to zero disability from stroke if emergency medical system response times and in-hospital response times are optimized (maximum time from symptom onset to intravenous thrombolysis is 4.5 hours). Black and Hispanic Americans have higher stroke incidence compared to Whites and are less likely to receive thrombolysis for acute stroke. The latency to hospital arrival is largely dependent on patients' recognition of stroke symptoms, and immediate presentation to the emergency department. The investigators have found very low stroke literacy rates among Blacks and Hispanics compared to Whites, which may, in part, be responsible for disparities in acute stroke treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Community Health Education, Minority Health, healthcare disparities
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants will receive education through a novel program called Stroke Education Film Viewing.
Arm Title
Usual Care Group
Arm Type
Other
Arm Description
Participants will receive education through Stroke Education Pamphlet Exposure.
Intervention Type
Behavioral
Intervention Name(s)
Stroke Education Film Viewing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stroke Education Pamphlet Exposure
Intervention Description
"Usual Care": Stroke Education pamphlet and brochure distribution.
Primary Outcome Measure Information:
Title
Score on Stroke Action Test
Description
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.
Time Frame
Within one hour of stroke education intervention.
Secondary Outcome Measure Information:
Title
Score on Stroke Action Test
Description
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.
Time Frame
Within six months of stroke education intervention.
Title
Score on Stroke Action Test
Description
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.
Time Frame
Within one year of stroke education intervention.
Other Pre-specified Outcome Measures:
Title
Time to emergency room after suffering a stroke
Description
This measures the time in getting to the emergency room after having suffered a stroke.
Time Frame
Up to 3.5 years post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olajide. A Williams, MD, MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center, Neurological Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31260028
Citation
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.
Results Reference
derived
PubMed Identifier
25927452
Citation
Ravenell 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.
Results Reference
derived
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Tailored Approaches to Stroke Health Education
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