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

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Stroke

Treatments

Behavioral: THRIVES

Study type

Interventional

Funder types

Other

Identifiers

NCT01900756
1U01NS079179

Details and patient eligibility

About

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.

Full 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).

Enrollment

400 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

400 participants in 2 patient groups

Behavioral
Active Comparator group
Description:
1. Pre-appointment phone text 2. In-clinic educational video 3. Patient report card 4. Post-clinic phone text 5. Outpatient stroke registry
Treatment:
Behavioral: THRIVES
Standard care
No Intervention group
Description:
Routine and customary management.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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