Preventing Recurrent Stroke in Minority Populations

Stroke Clinical Trial

Official title:

Improving the Delivery of Effective Care to Minorities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211731
• Other study ID #: 00-0053
• Secondary ID: P01HS010859-05
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: November 10, 2014
• Start date: September 2002
• Est. completion date: January 2007

Study information

• Verified date: December 2007
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Behavioral:
• Chronic Disease Self Management Course

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of under-use of effective secondary stroke preventive measures.
Secondary	Identification of the causes of under-use of effective secondary stroke preventive measures
Secondary	the characteristics of those patients