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Preventing Recurrent Stroke in Minority Populations

Primary Purpose

Stroke, Transient Ischemic Attack

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chronic Disease Self Management Course
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Acute stroke, recurrent stroke preventive measures, racial disparities

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Non-Hispanic white, Non-Hispanic Black or Hispanic patients hospitalized at one of the four participating hospitals for acute stroke or TIA or rehabilitation immediately following an acute stroke. Patients must speak English or Spanish, must be able to communicate verbally, and must be cognitively aware and able to participate in group discussions. Exclusion Criteria: This study is about racial and ethnic disparities regarding recurrent stroke in Non-Hispanic white, Non-Hispanic Black and Hispanic populations. The study does not include other races. We are excluding anyone who is under 40 years old because the etiology of stroke for these patients is different than older patients. Patients will be excluded who had a stroke secondary to substance abuse or who had an intra-cerebral hemorrhage stroke. We will also exclude patients who have been incapacitated to an extent that they are unable to comprehend a conversation or communicate effectively in a group setting. Additionally, patients will be excluded if they are discharged to a nursing home or who will move out of the New York City area after discharge.

Sites / Locations

  • Mount Sinai School of Medicine

Outcomes

Primary Outcome Measures

Identification of under-use of effective secondary stroke preventive measures.

Secondary Outcome Measures

Identification of the causes of under-use of effective secondary stroke preventive measures
the characteristics of those patients

Full Information

First Posted
September 13, 2005
Last Updated
November 10, 2014
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT00211731
Brief Title
Preventing Recurrent Stroke in Minority Populations
Official Title
Improving the Delivery of Effective Care to Minorities
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

5. Study Description

Brief Summary
This study focuses on causes of under-use of secondary stroke preventive measures demonstrated in randomized clinical trials to be efficacious, but not appropriately utilized in urban, minority populations.
Detailed Description
As the population ages and the number of prevalent strokes increases recurrent stroke is becoming an increasingly important health care burden. National and local data strongly suggest that this burden falls disproportionately on minority populations, notably Blacks and Hispanics. This study seeks to determine the factors that contribute to that disparity and design and implement a novel intervention tailored to alleviate the factors identified. Specifically it will focus on causes of under-use of stroke preventive measures demonstrated in randomized clinical trials to be efficacious, but not appropriately utilized in urban, minority populations. In the first phase of the study, charts of acute stroke patients in 4 large urban hospitals that serve the 3 racial/ethnic groups under study (Blacks, Hispanics and non-Hispanic whites) will be reviewed to determine the magnitude of under-use of these measures. Simultaneously, a panel of local expert physicians will finalize the proposed criteria for appropriate attention to risk factor assessment and modification. In the second phase of the proposed work, we will conduct a randomized trial intervention strategy that will include a control arm, and a patient educational arm where participants will be enrolled in a Chronic Disease Self Management Program. The program is designed to teach patients tools for managing their chronic illness which will empower them to improve their overall health. The program will be specifically tailored for patients living with asymptomatic chronic illnesses and will emphasize communication with health care providers. The educational intervention will be accompanied by a two-phased chart abstraction to measure clinical markers pre and post intervention. In the final phase of the study, the results of the trial will be analyzed and the results disseminated

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack
Keywords
Acute stroke, recurrent stroke preventive measures, racial disparities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Chronic Disease Self Management Course
Primary Outcome Measure Information:
Title
Identification of under-use of effective secondary stroke preventive measures.
Secondary Outcome Measure Information:
Title
Identification of the causes of under-use of effective secondary stroke preventive measures
Title
the characteristics of those patients

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-Hispanic white, Non-Hispanic Black or Hispanic patients hospitalized at one of the four participating hospitals for acute stroke or TIA or rehabilitation immediately following an acute stroke. Patients must speak English or Spanish, must be able to communicate verbally, and must be cognitively aware and able to participate in group discussions. Exclusion Criteria: This study is about racial and ethnic disparities regarding recurrent stroke in Non-Hispanic white, Non-Hispanic Black and Hispanic populations. The study does not include other races. We are excluding anyone who is under 40 years old because the etiology of stroke for these patients is different than older patients. Patients will be excluded who had a stroke secondary to substance abuse or who had an intra-cerebral hemorrhage stroke. We will also exclude patients who have been incapacitated to an extent that they are unable to comprehend a conversation or communicate effectively in a group setting. Additionally, patients will be excluded if they are discharged to a nursing home or who will move out of the New York City area after discharge.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Chassin, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Preventing Recurrent Stroke in Minority Populations

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