Clinical trial NCT01900756: Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke
Official title: Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-07-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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).

Primary outcomes:
measure: Reduction in systolic blood pressure
timeFrame: 1 year
Secondary outcomes:
measure: Reduced rate of subsequent primary vascular event
timeFrame: 1 year
Other outcomes:
measure: Reduction of disability and enhanced quality of life.
timeFrame: 1 year
Locations:
city: Abeokuta
country: Nigeria
facility: Sacred Heart Hospital
state: Ogun
city: Abeokuta
country: Nigeria
facility: Federal Medical Centre
city: Ibadan
country: Nigeria
facility: University College Hospital
Study officials:
References:
citation: Owolabi MO, Gebregziabher M, Akinyemi RO, Akinyemi JO, Akpa O, Olaniyan O, Salako BL, Arulogun O, Tagge R, Uvere E, Fakunle A, Ovbiagele B. Randomized Trial of an Intervention to Improve Blood Pressure Control in Stroke Survivors. Circ Cardiovasc Qual Outcomes. 2019 Dec;12(12):e005904. doi: 10.1161/CIRCOUTCOMES.119.005904. Epub 2019 Dec 6.
citation: Owolabi MO, Akinyemi RO, Gebregziabher M, Olaniyan O, Salako BL, Arulogun O, Ovbiagele B. Randomized controlled trial of a multipronged intervention to improve blood pressure control among stroke survivors in Nigeria. Int J Stroke. 2014 Dec;9(8):1109-16. doi: 10.1111/ijs.12331. Epub 2014 Jul 18.