Fred Sarfo1, Frank Treiber2, Mulugeta Gebregziabher2, Sheila Adamu2, Sachin Patel2, Michelle Nichols2, Dominic Awuah2, Asumadu Sakyi2, Nyantakyi Adu-Darko2, Arti Singh2, Raelle Tagge2, Jenkins Carolyn2, Bruce Ovbiagele2. 1. From the Division of Neurology, Department of Medicine, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana (F.S., A.S.); Department of Medicine, Komfo Anokye Teaching Hospital, Kumasi, Ghana (F.S., S.A., D.A., A.S., N.A.-D.); and Department of Neurology, Medical University of South Carolina, Charleston (F.T., M.G., S.P., M.N., R.T., J.C., B.O.). stephensarfo78@gmail.com. 2. From the Division of Neurology, Department of Medicine, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana (F.S., A.S.); Department of Medicine, Komfo Anokye Teaching Hospital, Kumasi, Ghana (F.S., S.A., D.A., A.S., N.A.-D.); and Department of Neurology, Medical University of South Carolina, Charleston (F.T., M.G., S.P., M.N., R.T., J.C., B.O.).
Abstract
BACKGROUND AND PURPOSE: Stroke exacts an immense toll in sub-Saharan Africa where there are few resources, and stroke prevention research is limited. The aim of this study is to test the feasibility and preliminary efficacy of an m-Health technology-enabled, nurse-guided intervention in improving blood pressure (BP) control among Ghanaian stroke patients within 1 month of symptom onset. METHODS: We conducted a 2-arm cluster pilot randomized controlled trial involving 60 recent stroke survivors encountered within a single tertiary medical system in Ghana. Subjects in the intervention arm (n=30) received a Blue-toothed UA-767Plus BT BP device and smartphone for monitoring and reporting BP measurements and medication intake for 3 months compared with standard of care (n=30). Primary outcome measure was systolic BP <140 mm Hg at month 3; secondary outcomes included medication adherence and autonomous self-regulation. Analysis accounting for clustering was made using generalized linear mixed model by intention to treat. RESULTS:Mean±SD age was 55±13 years, 65% male. Systolic BP <140 mm Hg at month 3 was found in 20/30 subjects (66.7%) in the intervention arm versus 14/30 subjects (46.7%) in the control arm (P=0.12). Medication possession ratio scores at month 3 were better in the intervention (0.88±0.40) versus control (0.64±0.45) arm (P=0.03). One subject in control arm died from a recurrent hemorrhagic stroke. CONCLUSIONS: It is feasible to conduct an m-Health-based, nurse-guided BP control intervention among recent stroke patients in sub-Saharan Africa. We observed a potential signal of efficacy with the intervention, which will need to be tested in a future large definitive study. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02568137.
RCT Entities:
BACKGROUND AND PURPOSE:Stroke exacts an immense toll in sub-Saharan Africa where there are few resources, and stroke prevention research is limited. The aim of this study is to test the feasibility and preliminary efficacy of an m-Health technology-enabled, nurse-guided intervention in improving blood pressure (BP) control among Ghanaian strokepatients within 1 month of symptom onset. METHODS: We conducted a 2-arm cluster pilot randomized controlled trial involving 60 recent stroke survivors encountered within a single tertiary medical system in Ghana. Subjects in the intervention arm (n=30) received a Blue-toothed UA-767Plus BT BP device and smartphone for monitoring and reporting BP measurements and medication intake for 3 months compared with standard of care (n=30). Primary outcome measure was systolic BP <140 mm Hg at month 3; secondary outcomes included medication adherence and autonomous self-regulation. Analysis accounting for clustering was made using generalized linear mixed model by intention to treat. RESULTS: Mean±SD age was 55±13 years, 65% male. Systolic BP <140 mm Hg at month 3 was found in 20/30 subjects (66.7%) in the intervention arm versus 14/30 subjects (46.7%) in the control arm (P=0.12). Medication possession ratio scores at month 3 were better in the intervention (0.88±0.40) versus control (0.64±0.45) arm (P=0.03). One subject in control arm died from a recurrent hemorrhagic stroke. CONCLUSIONS: It is feasible to conduct an m-Health-based, nurse-guided BP control intervention among recent strokepatients in sub-Saharan Africa. We observed a potential signal of efficacy with the intervention, which will need to be tested in a future large definitive study. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02568137.
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