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Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia (PROTECT DC)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PROTECT DC
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring ischemic stroke, stroke, cerebrovascular stroke, cerebrovascular accident, CVA, community health services, community health workers, navigators, health education, barriers to care, healthcare access, healthcare disparities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)
  • 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.

Exclusion Criteria:

  • 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)

Sites / Locations

  • Georgetown University Hospital
  • National Rehabilitation Hospital
  • Washington Hospital Center
  • Providence Hospital
  • George Washington University Hospital
  • Howard University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Navigation Group

Control Group

Arm Description

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.

Participants enrolled in this group will receive periodic follow up through mailings, phone calls etc to ensure availability for 1 year assessment.

Outcomes

Primary Outcome Measures

Low Density Lipoprotein Value
Systolic Blood Pressure Value
Hemoglobin A1C Value
Pill count of antiplatelet therapy medications

Secondary Outcome Measures

Smoking Cessation Status
AHA Diet Status
Exercise Status
Stroke Knowledge Level

Full Information

First Posted
June 20, 2008
Last Updated
February 20, 2013
Sponsor
Georgetown University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00703274
Brief Title
Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia
Acronym
PROTECT DC
Official Title
Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navigation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants enrolled in this group will receive periodic follow up through mailings, phone calls etc to ensure availability for 1 year assessment.
Intervention Type
Behavioral
Intervention Name(s)
PROTECT DC
Other Intervention Name(s)
navigator model, navigation intervention, community health worker intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Low Density Lipoprotein Value
Time Frame
1 year
Title
Systolic Blood Pressure Value
Time Frame
1 year
Title
Hemoglobin A1C Value
Time Frame
1 year
Title
Pill count of antiplatelet therapy medications
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Smoking Cessation Status
Time Frame
1 year
Title
AHA Diet Status
Time Frame
1 year
Title
Exercise Status
Time Frame
1 year
Title
Stroke Knowledge Level
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) 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. Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Dromerick, MD
Organizational Affiliation
National Rehabilitation Hospital, Georgetown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chelsea S. Kidwell, MD
Organizational Affiliation
Washington Hospital Center, National Rehabilitation Hospital, Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
National Rehabilitation Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Providence Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21951411
Citation
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.
Results Reference
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Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia

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