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

Completed

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • PROTECT DC Behavioral
    Other Names: navigator model; navigation intervention; community health worker intervention
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Navigation Group
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Supportive Care
  • Intervention: Parallel Assignment

Patient Involvement

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. 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Low Density Lipoprotein Value; Systolic Blood Pressure Value; Hemoglobin A1C Value; Pill count of antiplatelet therapy medications.
Secondary Smoking Cessation Status; AHA Diet Status; Exercise Status; Stroke Knowledge Level.
Primary Low Density Lipoprotein Value 1 year No
Primary Systolic Blood Pressure Value 1 year No
Primary Hemoglobin A1C Value 1 year No
Primary Pill count of antiplatelet therapy medications 1 year No
Secondary Smoking Cessation Status 1 year No
Secondary AHA Diet Status 1 year No
Secondary Exercise Status 1 year No
Secondary Stroke Knowledge Level 1 year No

Sponsors