Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke "THRIVES"

Active, not recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to determine whether a culturally-sensitive multipronged post-discharge intervention can significantly reduce blood pressure, enhance achievement of guideline recommended targets for risk factor control, and lower recurrent vascular events in a low-income and middle-income (LMIC). The study will have 2 Phases - a qualitative phase (Phase 1) lasting less than one year involving development of the intervention through focus group methodologies and structured interviews, and a clinical trial phase (Phase 2)lasting 3 years involving a randomized trial testing the efficacy of the intervention.

Detailed Description

This research seeks to develop an effective and sustainable way of reducing the devastating and deadly impact of stroke in a low-income region of the world with poor medical infrastructure. It will do so by focusing on improving the treatment of the condition most closely tied to stroke, hypertension, using novel methods that incorporate the input of the local community. If successful, the strategy could serve as a ready model to be adapted by decision-makers in other under-resourced areas for lessening the burden of stroke(and other major public health challenges).

Conditions

Interventions

  • THRIVES Behavioral
    Intervention Desc: Pre-appointment phone text In-clinic educational video Patient report card Post-clinic phone text Outpatient stroke registry
    ARM 1: Kind: Experimental
    Label: Behavioral
    Description: Pre-appointment phone text In-clinic educational video Patient report card Post-clinic phone text Outpatient stroke registry

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment
  • Perspective: Prospective

Outcomes

Type Measure Time Frame Safety Issue
Primary Reduction in systolic blood pressure 1 year No
Secondary Reduced rate of subsequent primary vascular event 1 year No

Sponsors