Effect of an Educational Intervention for Primary Stroke Risk Reduction in Ghana and Nigeria: Pilot Randomized Controlled Trial

Abstract

Background: Using tailored mobile health interventions to improve global vascular risk awareness and control is yet to be investigated for primary stroke prevention in Africa. Methods: This 2-arm pilot randomized controlled trial involved 100 stroke-free adults with at least 2 vascular risk factors for stroke. Eligible participants were assigned randomly to a control arm offering 1-time counseling (n=50) or a 2-month educational intervention arm (n=50) comprising a stroke video and riskometer app aimed at improving stroke risk factor awareness and health-seeking behavioral modification to control total vascular risk. Reduction in total stroke risk score was the primary outcome while feasibility and process measures were secondary outcomes. Results: All enrolled participants completed the 2-month follow-up (retention rate=100%). The mean (SD) age of participants was 59.5 (±12.5) years, 38% were males. The mean change in stroke risk score at 2 months was −11.9% (±14.2) in the intervention arm versus −1.2% (±9.1) in the control arm, P =0.0001. Stroke risk awareness improved by 16.1% (±24.7) in the intervention arm versus 8.9% (±24.7) in the control arm, P =0.08. The intervention arm had 11.1 mm Hg reduction in systolic blood pressure compared with 4.8 mm Hg reduction in the control arm. Conclusions: The intervention demonstrated a positive signal of effect over a 2-month period. A definitive clinical trial with a longer duration of follow-up is warranted on the premise of these promising findings from this pilot randomized clinical trial. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05619406.