Phone-Based Intervention Under Nurse Guidance for Control of Hypertension After Stroke: A Randomized Multicenter Phase 3 Trial in Ghana.

Abstract (English)

BACKGROUND: Addressing the rising burden of stroke in low-income countries will require pragmatic and scalable interventions targeting major risk factors. Under routine care settings, <10% of adults living with hypertension ever achieve blood pressure control, accentuating risks for adverse vascular events. The effectiveness of mobile health-centered, nurse-led interventions for the control of hypertension among patients with recent stroke in a resource-limited African setting is unknown. METHODS: The PINGS (Phone-Based Intervention Under Nurse Guidance After Stroke II) trial compared the efficacy and safety of usual care versus a 12-month intervention comprising home blood pressure self-monitoring with nurse case management for elevated home blood pressure recordings, use of phone alarms as medication reminders, and once-weekly education about cardiovascular risk reduction delivered by regular telephonic audio messages in selected Ghanaian dialects. This was a multicenter, randomized, open-label, blinded end point evaluation trial conducted at 10 hospitals between October 23, 2020, and April 5, 2024. We enrolled 500 patients ≥18 years with stroke within 1 month of onset and elevated blood pressure ≥140 or ≥90 mm Hg. The primary outcome was systolic blood pressure <140 mm Hg at month 12 by intention-to-treat principle. Secondary outcomes included major adverse cardiovascular events and serious adverse events. RESULTS: A total of 244 participants were assigned to the intervention group (PINGS) and 256 to the usual care group, of whom 43% were women, with mean (SD) age 58 (11) years. Mean change in systolic blood pressure at month 12 from baseline was -5.5 mm Hg (95% CI, -9.6 to -1.4 mm Hg; <i>P</i>=0.008). The primary outcome was achieved in 163 (67%) patients with PINGS versus 109 (43%) in the usual care arm, with a between-group difference of 24% (95% CI, 15%-33%; <i>P</i><0.001). No significant between-group differences were noted in the secondary outcome of major adverse cardiovascular events or the presumed key mediator of medication adherence. Serious adverse events were 27 of 244 (11.1%) with PINGS versus 18 of 256 (7.0%) in usual care (<i>P</i>=0.12). CONCLUSIONS: Leveraging mobile health intervention with minimal sophistication and task shifting to nurses on top of usual care safely improved blood pressure control among stroke survivors in a low-resource setting. Further study is warranted to confirm these findings and understand outcome drivers. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04404166.