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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: THRIVES

• Registration Number: NCT01900756
• Lead Sponsor: Medical University of South Carolina

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).

Study Timeline

• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-16
• Study Start: 2014-09
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral	THRIVES	1. Pre-appointment phone text 2. In-clinic educational video 3. Patient report card 4. Post-clinic phone text 5. Outpatient stroke registry

Primary Outcome Measures

Name	Time	Method
Reduction in systolic blood pressure	1 year	Reduction in systolic blood pressure at one year post-discharge in stroke patients.

Secondary Outcome Measures

Name	Time	Method
Reduced rate of subsequent primary vascular event	1 year

Trial Locations

Locations (3)

Sacred Heart Hospital; 🇳🇬 Abeokuta, Ogun, Nigeria

Federal Medical Centre; 🇳🇬 Abeokuta, Nigeria

University College Hospital; 🇳🇬 Ibadan, Nigeria