Discharge Educational Strategies for Reduction of Vascular Events
DESERVE
1 other identifier
interventional
552
1 country
3
Brief Summary
DESERVE is a discharge education study using health workers to enroll and randomly assign 800 subjects diagnosed with TIA, or mild stroke to either risk factor education or usual care. Those patients assigned to education will receive stroke preparedness education plus risk factor reduction education, and help accessing follow up care with health workers. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 17, 2013
CompletedFirst Posted
Study publicly available on registry
April 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedFebruary 17, 2020
February 1, 2020
3.8 years
April 17, 2013
February 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Pressure
change in overall blood pressure
6 months and 1 year
Secondary Outcomes (1)
Secondary Incident
up to 3 years
Study Arms (2)
DESERVE education
ACTIVE COMPARATORIntervention group will receive education on stroke preparedness plus risk factor reduction education, and help accessing follow up care with health workers.
Usual Care
NO INTERVENTIONThe usual care group will only receive written preparedness education, which is the standard care for the hospital.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Columbia Universitycollaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
Study Sites (3)
NYU Langone Medical Center
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Related Publications (3)
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.
PMID: 34813082DERIVEDGoldmann 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.
PMID: 32340524DERIVEDBoden-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.
PMID: 30304326DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernadette Boden-Albala, DrPH
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2013
First Posted
April 19, 2013
Study Start
August 1, 2012
Primary Completion
June 1, 2016
Study Completion
November 1, 2019
Last Updated
February 17, 2020
Record last verified: 2020-02