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Completed

NCT Number: NCT00211731

Preventing Recurrent Stroke in Minority Populations

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai School of Medicine

New York, 10029, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chronic Disease Self Management Course

Behavioral

Primary outcomes

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

Secondary outcomes

  1. Identification of the causes of under-use of effective secondary stroke preventive measures

  2. the characteristics of those patients

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Improving the Delivery of Effective Care to Minorities

Important dates

Study start
2002
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Nov 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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