StrokePhase 2PROTECT DCNCT00703274
Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia
A Phase 2 study testing PROTECT DC in people with Stroke, run by Georgetown University at 6 sites in United States.
Trial summary
The purpose of this study is to refine and evaluate the Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- PROTECT DC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2008to Jan 2013
- Phase
- Phase 2
- 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
- Age ≥ 18 years
- Hospitalized due to ischemic stroke* or intercurrent ischemic stroke* event within the past 30 days OR Transient ischemic attack, confirmed by stroke neurologist.
- Atherogenic etiology(large vessel, small vessel, cryptogenic with at least one stroke risk factor, or embolic stroke due to atherogenic cardiac disease) as defined by TOAST criteria.
- Community dwelling prior to stroke
- Resides within the District of Columbia or closely nearby (preferably within 10 miles of the DC border)
- Expected to reside within the District of Columbia or closely nearby (preferably within 10 miles of DC border)
Show all 9Show fewer
- Caregiver or interested party available, if moderately or severely disabled (not required to actually reside with participant)
- Sufficient number of collateral contacts to assure follow-up. Defined as: Preferred: at least 6 contacts; and No fewer than 3 contacts (unless approved by study PI/co-PI/co-I)
- Judged likely to return to community setting at completion of post-acute care.
Who cannot join
- Non-atherogenic cause of stroke
- NIHSS > 20
- Any medical condition that would limit participation in follow up assessments
- Baseline dementia per informant report (AD8) or screening assessment (Short Blessed Memory Orientation Concentration Test)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Providence Hospital
Washington D.C., District of Columbia, 20017
George Washington University Hospital
Washington D.C., District of Columbia, 20037
Howard University Hospital
Washington D.C., District of Columbia, 20060
About this study
The purpose of this study is to refine and evaluate the Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) intervention. PROTECT DC is a program consisting of in-hospital education coupled with community-based "stroke navigators" and is designed to reduce the rate of vascular events or death in a population of underserved individuals with stroke.
Read the detailed description
Despite significant advances in the prevention and treatment of cerebrovascular disease in the last few decades, stroke remains the third leading cause of death and the leading cause of adult disability in the United States. For the population that has experienced a cerebrovascular event, the risk of future stroke is greatly increased. The initiation of effective secondary prevention strategies is most effective when implemented early (before disabling stroke occurs), monitored frequently, and maintained long-term after a cerebrovascular event.
The Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) intervention uses stroke navigators to help people who have suffered a stroke implement secondary prevention strategies. Stroke navigators are lay persons trained to provide education on secondary prevention behavior, and trained to navigate the health and human service system. The goals are to help individuals who have had a stroke obtain the necessary services and programs to engage in secondary prevention behaviors and, ultimately, to prevent the recurrence of stroke.
- Conditions
- Stroke
- Being tested
- PROTECT DC
- Keywords
- ischemic stroke, stroke, cerebrovascular stroke, cerebrovascular accident, CVA, community health services, community health workers, navigators, health education, barriers to care, healthcare access, healthcare disparities
- Medical subject headings
- Stroke, Ischemic Stroke, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROTECT DCBehavioural
Also called navigator model, navigation intervention, community health worker intervention
PROTECT DC facilitates the initiation of secondary prevention behaviors in an attempt to prevent the recurrence of stroke among participants. The program trains a lay person, called a stroke navigator, to provide participants with education on secondary prevention behavior and to navigate the health and human service system, which will assist participants in obtaining the necessary services and programs to engage in secondary prevention behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Navigation Group | Experimental | Participants enrolled in this group will receive education concerning primary and secondary PROTECT DC goals. Primary PROTECT DC goals adhere to the following medication directives: 1) Anti-hypertensive, 2) Lipid Lowering, 3) Anti-Coagulant, and 4) Anti-Diabetic. PROTECT DC secondary goals include the following behaviors 1) Smoking Cessation, 2) Consuming an AHA Diet, 3) Regular Exercise, and 4) Knowledge of Stroke Risk and Warning Signs. Participants will also receive assistance with overcoming resource-related barriers to the PROTECT DC goals. Receives: Behavioral: PROTECT DC |
| Control Group | No intervention | Participants enrolled in this group will receive periodic follow up through mailings, phone calls etc to ensure availability for 1 year assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Density Lipoprotein Value
Measured: 1 year
Systolic Blood Pressure Value
Measured: 1 year
Hemoglobin A1C Value
Measured: 1 year
Pill count of antiplatelet therapy medications
Measured: 1 year
Secondary outcomes (4)
Smoking Cessation Status
Measured: 1 year
AHA Diet Status
Measured: 1 year
Exercise Status
Measured: 1 year
Stroke Knowledge Level
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chelsea Kidwell, M.D., Georgetown University
- Investigators
- Alexander Dromerick, MD, Principal investigator, National Rehabilitation Hospital, Georgetown UniversityChelsea S. Kidwell, MD, Principal investigator, Washington Hospital Center, National Rehabilitation Hospital, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703274
- Sponsor's protocol ID
- U54NS057405
- Other IDs
- 1U54NS057405-01A1
- Acronym
- PROTECT DC
- Status last verified
- Feb 2013
- First submitted
- 20 Jun 2008
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dromerick AW, Gibbons MC, Edwards DF, Farr DE, Giannetti ML, Sanchez B, Shara NM, Fokar A, Jayam-Trouth A, Ovbiagele B, Kidwell CS. Preventing recurrence of thromboembolic events through coordinated treatment in the District of Columbia. Int J Stroke. 2011 Oct;6(5):454-60. doi: 10.1111/j.1747-4949.2011.00654.x.
PubMed 21951411
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia
- ClinicalTrials.gov ID
- NCT00703274
- Acronym / sponsor ID
- PROTECT DC / U54NS057405
- Conditions
- Stroke
- Keywords
- ischemic stroke, stroke, cerebrovascular stroke, cerebrovascular accident, CVA, community health services, community health workers, navigators
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Apr 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Jun 2008 (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.
The purpose of this study is to refine and evaluate the Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) intervention. PROTECT DC is a program consisting of in-hospital education coupled with community-based "stroke navigators" and is designed to reduce the rate of vascular events or death in a population of underserved individuals with stroke.
Detailed description
Despite significant advances in the prevention and treatment of cerebrovascular disease in the last few decades, stroke remains the third leading cause of death and the leading cause of adult disability in the United States. For the population that has experienced a cerebrovascular event, the risk of future stroke is greatly increased. The initiation of effective secondary prevention strategies is most effective when implemented early (before disabling stroke occurs), monitored frequently, and maintained long-term after a cerebrovascular event.
The Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) intervention uses stroke navigators to help people who have suffered a stroke implement secondary prevention strategies. Stroke navigators are lay persons trained to provide education on secondary prevention behavior, and trained to navigate the health and human service system. The goals are to help individuals who have had a stroke obtain the necessary services and programs to engage in secondary prevention behaviors and, ultimately, to prevent the recurrence of stroke.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigation Group | Experimental | Behavioral: PROTECT DCParticipants enrolled in this group will receive education concerning primary and secondary PROTECT DC goals. Primary PROTECT DC goals adhere to the following medication directives: 1) Anti-hypertensive, 2) Lipid Lowering, 3) Anti-Coagulant, and 4) Anti-Diabetic. PROTECT DC secondary goals include the following behaviors 1) Smoking Cessation, 2) Consuming an AHA Diet, 3) Regular Exercise, and 4) Knowledge of Stroke Risk and Warning Signs. Participants will also receive assistance with overcoming resource-related barriers to the PROTECT DC goals. |
| Control Group | No intervention | –Participants enrolled in this group will receive periodic follow up through mailings, phone calls etc to ensure availability for 1 year assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Hospitalized due to ischemic stroke* or intercurrent ischemic stroke* event within the past 30 days OR Transient ischemic attack, confirmed by stroke neurologist.
- Atherogenic etiology(large vessel, small vessel, cryptogenic with at least one stroke risk factor, or embolic stroke due to atherogenic cardiac disease) as defined by TOAST criteria.
- Community dwelling prior to stroke
- Resides within the District of Columbia or closely nearby (preferably within 10 miles of the DC border)
Key exclusion criteria (4 listed)
- Non-atherogenic cause of stroke
- NIHSS > 20
- Any medical condition that would limit participation in follow up assessments
- Baseline dementia per informant report (AD8) or screening assessment (Short Blessed Memory Orientation Concentration Test)
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 |
|---|---|---|
| PROTECT DCAlso: navigator model, navigation intervention, community health worker interventionPROTECT DC facilitates the initiation of secondary prevention behaviors in an attempt to prevent the recurrence of stroke among participants. The program trains a lay person, called a stroke navigator, to provide participants with education on secondary prevention behavior and to navigate the health and human service system, which will assist participants in obtaining the necessary services and programs to engage in secondary prevention behaviors. | Behavioural | Navigation Group |
Primary outcome
Low Density Lipoprotein Value
Time frame: 1 year
Systolic Blood Pressure Value
Time frame: 1 year
Hemoglobin A1C Value
Time frame: 1 year
Pill count of antiplatelet therapy medications
Time frame: 1 year
4 secondary outcomes
Smoking Cessation Status
Time frame: 1 year
AHA Diet Status
Time frame: 1 year
Exercise Status
Time frame: 1 year
Stroke Knowledge Level
Time frame: 1 year
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 21 Feb 2013.
- Background: PubMed 21951411Dromerick AW, Gibbons MC, Edwards DF, Farr DE, Giannetti ML, Sanchez B, Shara NM, Fokar A, Jayam-Trouth A, Ovbiagele B, Kidwell CS. Preventing recurrence of thromboembolic events through coordinated treatment in the District of Columbia. Int J Stroke. 2011 Oct;6(5):454-60. doi: 10.1111/j.1747-4949.2011.00654.x.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Alexander Dromerick, MD principal investigator
National Rehabilitation Hospital, Georgetown University
Chelsea S. Kidwell, MD principal investigator
Washington Hospital Center, National Rehabilitation Hospital, Georgetown University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PROTECT DC in people with Stroke, run by Georgetown University at 6 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 9 inclusion and 4 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 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Low Density Lipoprotein Value (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT00703274, which also lists 1 linked publication.
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 21 Feb 2013.