Intracerebral InfarctsDESERVENCT01836354
Discharge Educational Strategies for Reduction of Vascular Events
A study testing DESERVE education in people with Intracerebral Infarcts and Ischemic Stroke, run by NYU Langone Health at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Infarcts, Ischemic Stroke, Hemorrhagic Strokes
- What is being tested?
- DESERVE education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2012to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NYU Langone Medical Center
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University
New York, New York, 10032
About this study
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.
Read the detailed description
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.
- Conditions
- Intracerebral Infarcts, Ischemic Stroke, Hemorrhagic Strokes, TIA's
- Being tested
- DESERVE education
- Keywords
- stroke, interactive educational intervention, acute ischemic stroke, transient ischemic attack
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESERVE educationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| DESERVE education | Active comparator | Intervention group will receive education on stroke preparedness plus risk factor reduction education, and help accessing follow up care with health workers. Receives: Behavioral: DESERVE education |
| Usual Care | No intervention | The usual care group will only receive written preparedness education, which is the standard care for the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
change in overall blood pressure
Measured: 6 months and 1 year
Secondary outcomes (1)
Secondary Incident
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.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startAug 2012
- Primary completion1 Jun 2016
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracerebral InfarctsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernadette Boden-Albala, DrPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836354
- Sponsor's protocol ID
- 14-00718
- Acronym
- DESERVE
- Status last verified
- Feb 2020
- First submitted
- 17 Apr 2013
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34813082Goldmann 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.
PubMed 32340524Boden-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.
PubMed 30304326
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discharge Educational Strategies for Reduction of Vascular Events
- ClinicalTrials.gov ID
- NCT01836354
- Acronym / sponsor ID
- DESERVE / 14-00718
- Conditions
- Intracerebral Infarcts, Ischemic Stroke, Hemorrhagic Strokes, TIA's
- Keywords
- stroke, interactive educational intervention, acute ischemic stroke, transient ischemic attack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Columbia University, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Aug 2012 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DESERVE education | Active comparator | Behavioral: DESERVE educationIntervention group will receive education on stroke preparedness plus risk factor reduction education, and help accessing follow up care with health workers. |
| Usual Care | No intervention | –The usual care group will only receive written preparedness education, which is the standard care for the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DESERVE educationThose 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 | Behavioural | DESERVE education |
Primary outcome
Blood Pressure
Time frame: 6 months and 1 year
change in overall blood pressure
1 secondary outcome
Secondary Incident
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 34813082Crocker 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.
- Derived from this study: PubMed 32340524Goldmann 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.
- Derived from this study: PubMed 30304326Boden-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernadette Boden-Albala, DrPH principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DESERVE education in people with Intracerebral Infarcts and Ischemic Stroke, run by NYU Langone Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01836354, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.