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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01900756
Acronym
THRIVES
Enrollment
400
Registered
2013-07-16
Start date
2014-09-30
Completion date
2017-11-30
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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).

Interventions

BEHAVIORALTHRIVES

Pre-appointment phone text In-clinic educational video Patient report card Post-clinic phone text Outpatient stroke registry

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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).

Design outcomes

Primary

MeasureTime frameDescription
Reduction in systolic blood pressure1 yearReduction in systolic blood pressure at one year post-discharge in stroke patients.

Secondary

MeasureTime frame
Reduced rate of subsequent primary vascular event1 year

Other

MeasureTime frame
Reduction of disability and enhanced quality of life.1 year

Countries

Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026