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

July 22, 2013
November 12, 2013
July 2013
June 2018   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01909271 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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.
Same as current
 
Tailored Approaches to Stroke Health Education
Tailored Approaches to Stroke Health Education

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Stroke
  • 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.
  • 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.
    Intervention: Behavioral: Stroke Education Film Viewing
  • Usual Care Group
    "Usual Care": Stroke Education pamphlet and brochure distribution.
    Intervention: Other: Stroke Education Pamphlet Exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
266
June 2018
June 2018   (final data collection date for primary outcome measure)

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.
Both
34 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01909271
AAAK5853, 1U54NS081765-01
Yes
Olajide Williams, Columbia University
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Olajide A Williams, MD MS Columbia University
Columbia University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP