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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: THRIVES


Participation Criteria
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Eligibility Criteria
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Phase 1: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Behavioral<br>Pre-appointment phone text In-clinic educational video Patient report card Post-clinic phone text Outpatient stroke registry | Behavioral: THRIVES<br>* Pre-appointment phone text In-clinic educational video Patient report card Post-clinic phone text Outpatient stroke registry<br>|
| No Intervention: Standard care<br>Routine and customary management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in systolic blood pressure | Reduction in systolic blood pressure at one year post-discharge in stroke patients. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced rate of subsequent primary vascular event |  | 1 year |