TASHE: Tailored Approaches to Stroke Health Education

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT01909271
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
290
2
2
67.5
145
2.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Stroke Education Film Viewing
  • Other: Stroke Education Pamphlet Exposure
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
290 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Tailored Approaches to Stroke Health Education
Actual Study Start Date :
Apr 16, 2014
Actual Primary Completion Date :
Jun 8, 2017
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

Participants will receive education through a novel program called Stroke Education Film Viewing.

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: Usual Care Group

Participants will receive education through Stroke Education Pamphlet Exposure.

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

Outcome Measures

Primary Outcome Measures

  1. Score on Stroke Action Test [Within one hour of stroke education intervention.]

    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

  1. Score on Stroke Action Test [Within six months of stroke education intervention.]

    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.

  2. Score on Stroke Action Test [Within one year of stroke education intervention.]

    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.

Other Outcome Measures

  1. Time to emergency room after suffering a stroke [Up to 3.5 years post-intervention]

    This measures the time in getting to the emergency room after having suffered a stroke.

Eligibility Criteria

Criteria

Ages Eligible for Study:
34 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University Medical Center, Neurological Institute New York New York United States 10032
2 Columbia University Medical Center New York New York United States 10032

Sponsors and Collaborators

  • Columbia University
  • National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Olajide. A Williams, MD, MS, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olajide Williams, Chief of Staff of Neurology Associate Professor of Clinical Neurology, Columbia University
ClinicalTrials.gov Identifier:
NCT01909271
Other Study ID Numbers:
  • AAAK5853
  • 1U54NS081765-01
First Posted:
Jul 26, 2013
Last Update Posted:
Jul 15, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Olajide Williams, Chief of Staff of Neurology Associate Professor of Clinical Neurology, Columbia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 15, 2020