Circulation · 2026
Phone-Based Intervention Under Nurse Guidance for Control of Hypertension After Stroke: A Randomized Multicenter Phase 3 Trial in Ghana.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Sarfo Fred Stephen, Akpalu Albert, Bockarie Ansumana S, Nguah Samuel Blay, Ayisi-Boateng Nana Kwame, Adu Gyamfi Rexford, Arthur Agnes Amankwaah, Duah Christiana, Fiattor Timothy, Agyenim-Boateng Kwadwo Gyebi, Achab Emmanuel, Appiah Lambert Tetteh, Opare-Addo Priscilla Abrafi, Adamu Sheila, Agbenorku Manolo, Adusei-Mensah Nathaniel, Tagge Raelle, Ampofo Michael, Asibey Shadrack Osei, Laryea Ruth, MacCready Evans, Sam Victoria Aba, Buadu Kwaku Affrim, Adu Solomon, Adu Darko Nyantakyi, Agbogbatey Melvin, Amuasi John H, Ovbiagele Bruce
Аннотация
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; P=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%; P<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 (P=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.
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; P=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%; P<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 (P=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.