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| Sponsors and Collaborators: |
Mount Sinai School of Medicine Agency for Healthcare Research and Quality (AHRQ) |
|---|---|
| Information provided by: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00211731 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke Transient Ischemic Attack |
Behavioral: Chronic Disease Self Management Course |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Improving the Delivery of Effective Care to Minorities |
| Enrollment: | 87 |
| Study Start Date: | September 2002 |
| Study Completion Date: | January 2007 |
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
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| Principal Investigator: | Mark Chassin, MD | Mount Sinai School of Medicine |
More Information
| Study ID Numbers: | 00-0053, P01 HS10859-05 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 4, 2007 |
| ClinicalTrials.gov Identifier: | NCT00211731 |
| Health Authority: | United States: Institutional Review Board |
|
Acute stroke recurrent stroke preventive measures racial disparities |
|
Ischemic Attack, Transient Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases |
Brain Ischemia Ischemia Brain Diseases Cerebrovascular Disorders Recurrence |
|
Nervous System Diseases Cardiovascular Diseases |
