- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00211731
Preventing Recurrent Stroke in Minority Populations
Improving the Delivery of Effective Care to Minorities
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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New York
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New York, New York, Vereinigte Staaten, 10029
- Mount Sinai School of Medicine
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
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Identification of under-use of effective secondary stroke preventive measures.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
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Identification of the causes of under-use of effective secondary stroke preventive measures
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the characteristics of those patients
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Mark Chassin, MD, Icahn School of Medicine at Mount Sinai
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 00-0053
- P01HS010859-05 (US-AHRQ-Zuschuss/Vertrag)
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