Tailored Approaches to Stroke Health Education (TASHE)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Olajide Williams, Columbia University
ClinicalTrials.gov Identifier:
NCT01909271
First received: July 22, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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. Our group has 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. 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-min films (in English and Spanish), in minority populations in New York City. The investigators hypothesize that participants in the intervention arm (who view the stroke education film) will demonstrate greater behavioral intent to call 911 for suspected stroke compared to those in the usual care arm, who will receive written stroke education materials. Behavioral intent to call 911 will be assessed immediately after viewing the film, 6 months later, and one year later.


Condition Intervention
Stroke
Behavioral: Stroke Education Film Viewing
Other: Stroke Education Pamphlet Exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Tailored Approaches to Stroke Health Education

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Score on Stroke Action Test [ Time Frame: Within one hour of stroke education intervention. ] [ Designated as safety issue: No ]
    The validated Stroke Action Test will be used to measure behavioral intent to call 911 for suspected stroke. This test will be administered at immediate post intervention, 6 months and 1 year following the intervention compared to those in the usual care (UC) arm.


Secondary Outcome Measures:
  • Score on Stroke Action Test [ Time Frame: Within six months of stroke education intervention. ] [ Designated as safety issue: No ]
    The validated Stroke Action Test will be used to measure behavioral intent to call 911 for suspected stroke. This test will be administered at immediate post intervention, 6 months and 1 year following the intervention compared to those in the usual care (UC) arm.

  • Score on Stroke Action Test [ Time Frame: Within one year of stroke education intervention. ] [ Designated as safety issue: No ]
    The validated Stroke Action Test will be used to measure behavioral intent to call 911 for suspected stroke. This test will be administered at immediate post intervention, 6 months and 1 year following the intervention compared to those in the usual care (UC) arm.


Other Outcome Measures:
  • Time to emergency room after suffering a stroke [ Time Frame: Up to 3.5 years post-intervention ] [ Designated as safety issue: No ]
    The investigators hypothesize that subjects assigned to the intervention arm will demonstrate a smaller delay in getting to the emergency room after having suffered a stroke, compared to subjects in the control arm, using (an average of) 3.5 years follow-up.


Estimated Enrollment: 266
Study Start Date: July 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stroke Education Film Viewing Intervention Group
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.
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.
Usual Care Group
"Usual Care": Stroke Education pamphlet and brochure distribution.
Other: Stroke Education Pamphlet Exposure
"Usual Care": Stroke Education pamphlet and brochure distribution.

  Eligibility

Ages Eligible for Study:   34 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. No prior history of stroke;
  2. High risk (defined as a history of one or more stroke risk factor (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909271

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Columbia University Medical Center, Neurological Institute
New York City, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Olajide A Williams, MD MS Columbia University
  More Information

No publications provided

Responsible Party: Olajide Williams, Chief of Staff of Neurology Associate Professor of Clinical Neurology, Columbia University
ClinicalTrials.gov Identifier: NCT01909271     History of Changes
Other Study ID Numbers: AAAK5853, 1U54NS081765-01
Study First Received: July 22, 2013
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Columbia University:
Stroke
Community Health Education
Minority Health
healthcare disparities

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 01, 2014