Discharge Educational Strategies for Reduction of Vascular Events (DESERVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01836354|
Recruitment Status : Recruiting
First Posted : April 19, 2013
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Infarcts Ischemic Stroke Hemorrhagic Strokes TIA's||Behavioral: DESERVE education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Discharge Educational Strategies for Reduction of Vascular Events|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: DESERVE education
Intervention group will receive education on stroke preparedness plus risk factor reduction education, and help accessing follow up care with health workers.
Behavioral: DESERVE education
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
No Intervention: Usual Care
The usual care group will only receive written preparedness education, which is the standard care for the hospital.
- Blood Pressure [ Time Frame: 6 months and 1 year ]change in overall blood pressure
- Secondary Incident [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836354
|Contact: Bernadette Boden-Albala, DrPH||212-659-9322|
|United States, New York|
|NYU Langone Medical Center||Not yet recruiting|
|New York, New York, United States, 10016|
|Contact: Bernadette Boden-Albala, PhD|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Stanley Tuhrim, MD 212-241-7076 firstname.lastname@example.org|
|New York, New York, United States, 10032|
|Contact: Joshua Stillman, MD 212-342-1698 email@example.com|
|Principal Investigator:||Bernadette Boden-Albala, DrPH||Icahn School of Medicine at Mount Sinai|