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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-11-30

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.

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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).

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Behavioral

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

Group Type ACTIVE_COMPARATOR

THRIVES

Intervention Type BEHAVIORAL

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

Standard care

Routine and customary management.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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THRIVES

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No