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

Stroke Clinical Trial

— THRIVES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900756
• Other study ID #: 1U01NS079179
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 2017

Study information

• Verified date: May 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Nigeria	Federal Medical Centre	Abeokuta
Nigeria	Sacred Heart Hospital	Abeokuta	Ogun
Nigeria	University College Hospital	Ibadan

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction of disability and enhanced quality of life.		1 year
Primary	Reduction in systolic blood pressure	Reduction in systolic blood pressure at one year post-discharge in stroke patients.	1 year
Secondary	Reduced rate of subsequent primary vascular event		1 year