- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01836354
Discharge Educational Strategies for Reduction of Vascular Events (DESERVE)
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Stroke and its risk factors disproportionately affect minority populations, and secondary stroke prevention programs have had relatively little success. TIA and mild stroke patients with few after-affects also stay in the hospital for a shorter period of time, and leave without enough information about their risk for another stroke. Additionally, mild stroke and TIA patients often do not follow-up with neurologists after they leave the hospital. DESERVE is a discharge education study using health workers to enroll and randomly assign 800 subjects from MSSM, MSSM Queens and CUMC diagnosed with Transient Ischemic attack (TIA ), mild Ischemic stroke (IS) or mild Intracerebral Hemorrhage (ICH) to either risk factor education or usual care. Those patients assigned to education will receive education on stroke preparedness education plus risk factor reduction education, and help accessing follow up care with health workers. This education includes a power point presentation and a patient-paced workbook and video on Risk perception, Medication Adherence, and Patient-Physician Communication. To target the most appropriate mild IS/ICH and TIA survivors for participation in this proposal, we will focus on survivors with mild stroke and TIA, excluding those whose stroke deficits are severe enough to warrant discharge to a nursing home or to require 24-hour care.
Those patients assigned to usual care will receive written stroke preparedness education. This protocol will evaluate the effectiveness of this intervention to reduce blood pressure, and individual stroke risk factors and future stroke risk. Additionally, we will evaluate the ability of the these strategies to conduct education to affect positive change in taking medications as directed, stroke knowledge 6 months and 12 months after hospital admission, attendance at follow-up health care appointments, and cost-effectiveness. After 1 year participants will be followed quarterly for up to 3 years to track events.
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, 10032
- Columbia University
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New York, New York, Vereinigte Staaten, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, Vereinigte Staaten, 10016
- NYU Langone Medical Center
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Diagnosed with mild ischemic cerebral infarction or mild intracerebral hemorrhage (NIHSS < 5) or TIA based on a clinical definition of focal neurologic deficits consistent with a single vascular territory of the brain
- Aged greater than 18 years at onset of event
- Resident of NY Metropolitan community in home with land or cell phone.
- Vascular risk factors including HTN history or elevated blood pressure (>130/85 mmHg) at the time of discharge, smoking, diabetes or metabolic syndrome
- Discharge to home
- English or Spanish Speaker
Exclusion Criteria:
- Patients unable to give informed consent
- Discharged to long-term nursing home or requiring 24 hour care.
- A Modified Rankin score > 2 at baseline
- Pre-stroke dementia history.
- Patients with end stage cancer, or other medical conditions resulting in mortality less than 1 year.
- Patient does not speak English or Spanish.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: DESERVE education
Intervention group will receive education on stroke preparedness plus risk factor reduction education, and help accessing follow up care with health workers.
|
Those patients assigned to education will receive stroke comprehensive intervention which focuses on three main areas, Risk perception, Medication Adherence, and Patient-Physician Communication.
We will test whether phone calls and visits with a health worker after discharge, videos and a workbook are linked to better control of blood pressure and other risk factors
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Kein Eingriff: Usual Care
The usual care group will only receive written preparedness education, which is the standard care for the hospital.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Blood Pressure
Zeitfenster: 6 months and 1 year
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change in overall blood pressure
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6 months and 1 year
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Secondary Incident
Zeitfenster: up to 3 years
|
A secondary outcome is when the patient has a new visit to the ED or another hospital; admission that it is not a stroke/TIA nor ICH.
Instead, it might be a seizure, headache, migraine, anything else neurological.
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up to 3 years
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Bernadette Boden-Albala, DrPH, Icahn School of Medicine at Mount Sinai
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Goldmann E, Jacoby R, Finfer E, Appleton N, Parikh NS, Roberts ET, Boden-Albala B. Positive Health Beliefs and Blood Pressure Reduction in the DESERVE Study. J Am Heart Assoc. 2020 May 5;9(9):e014782. doi: 10.1161/JAHA.119.014782. Epub 2020 Apr 28.
- Boden-Albala B, Goldmann E, Parikh NS, Carman H, Roberts ET, Lord AS, Torrico V, Appleton N, Birkemeier J, Parides M, Quarles L. Efficacy of a Discharge Educational Strategy vs Standard Discharge Care on Reduction of Vascular Risk in Patients With Stroke and Transient Ischemic Attack: The DESERVE Randomized Clinical Trial. JAMA Neurol. 2019 Jan 1;76(1):20-27. doi: 10.1001/jamaneurol.2018.2926.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 14-00718
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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