Effect of an Educational Intervention for Primary Stroke Risk Reduction in Ghana and Nigeria: Pilot Randomized Controlled Trial
Fred Stephen Sarfo, Joshua Akinyemi, Reginald Obiako, Michelle Nichols, Adekunle Fakunle, Nathaniel Adusei, Michael Ampofo, Oyedunni Arulogun, Carolyn Jenkins, Onoja Akpa, Benjamin S. Aribisala, Saheed Abdulrasaq, Rufus Akinyemi, Bruce Ovbiagele, Mayowa Owolabi
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.