Tailored Approaches to Stroke Health Education

Stroke Clinical Trial

— TASHE  

Official title:

Tailored Approaches to Stroke Health Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909271
• Other study ID #: AAAK5853
• Secondary ID: 1U54NS081765-01
• Status: Completed
• Phase: N/A
• Start date: April 16, 2014
• Est. completion date: December 2019

Study information

• Verified date: July 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: December 2019
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 34 Years and older

Eligibility

Inclusion Criteria:

1. No prior history of stroke;

2. High risk (defined as a history of one or more stroke risk factor (hypertension (HTN), diabetes, tobacco, abdominal obesity, heart disease, high cholesterol);

3. 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 );

4. Self-identified as Black or Hispanic; and

5. Member of a church congregation who lives in a household with a telephone.

Exclusion Criteria:

1. Participant is unable to give consent;

2. A modified Rankin score > 4 at baseline;

3. history of dementia; and

4. terminal illness, or other medical illness resulting in mortality < 1 year.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Stroke Education Film Viewing
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.

Other:
• Stroke Education Pamphlet Exposure
"Usual Care": Stroke Education pamphlet and brochure distribution.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York
United States	Columbia University Medical Center, Neurological Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to emergency room after suffering a stroke	This measures the time in getting to the emergency room after having suffered a stroke.	Up to 3.5 years post-intervention
Primary	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	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 six months of stroke education intervention.
Secondary	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 year of stroke education intervention.