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Completed

NCT Number: NCT01900756

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sacred Heart Hospital, Abeokuta, Ogun State, Nigeria

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

THRIVES

Behavioral

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

Primary outcomes

  1. Reduction in systolic blood pressure

    Time frame: 1 year

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

Secondary outcomes

  1. Reduced rate of subsequent primary vascular event

    Time frame: 1 year

Other outcomes

  1. Reduction of disability and enhanced quality of life.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Acronym: THRIVES

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 16, 2013
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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