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Clinical Trials/NCT01900756
NCT01900756
Completed
Not Applicable

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

Medical University of South Carolina3 sites in 1 country400 target enrollmentSeptember 2014
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Medical University of South Carolina
Enrollment
400
Locations
3
Primary Endpoint
Reduction in systolic blood pressure
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
November 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years Stroke within one year access to mobile phone.

Exclusion Criteria

  • Any medical condition that would limit participation in follow up assessments, Severe cognitive impairment/dementia (MMSE ≤24) Severe global disability (modified Rankin Score ≥ 3).

Outcomes

Primary Outcomes

Reduction in systolic blood pressure

Time Frame: 1 year

Reduction in systolic blood pressure at one year post-discharge in stroke patients.

Secondary Outcomes

  • Reduced rate of subsequent primary vascular event(1 year)

Study Sites (3)

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