Mayowa O Owolabi1,2, Mulugeta Gebregziabher3, Rufus O Akinyemi1,4, Joshua O Akinyemi5, Onoja Akpa5, Olanrewaju Olaniyan6, Babatunde L Salako7, Oyedunni Arulogun8, Raelle Tagge9, Ezinne Uvere7,2, Adekunle Fakunle7, Bruce Ovbiagele10. 1. Department of Medicine, University College Hospital and University of Ibadan, Nigeria and Center for Genomic and Precision Medicine, College of Medicine (M.O.O., R.O.A.), University of Ibadan, Nigeria. 2. Blossom Specialist Medical Center, First Center for Neurorehabilitation, Ibadan, Nigeria (M.O.O., E.U.). 3. Division of Biostatistics and Bioinformatics, Department of Public Health Sciences (M.G.), Medical University of South Carolina. 4. Department of Medicine, Federal Medical Center, and Sacred Heart Hospital, Abeokuta, Nigeria (R.O.A.). 5. Department of Epidemiology and Medical Statistics (J.O.A., O. Akpa), University of Ibadan, Nigeria. 6. Department of Economics (O.O.), University of Ibadan, Nigeria. 7. Department of Medicine (B.L.S., E.U., A.F.), University of Ibadan, Nigeria. 8. Department of Health Promotion and Education (O. Arulogun), University of Ibadan, Nigeria. 9. Department of Neurosciences (R.T.), Medical University of South Carolina. 10. Department of Neurology, University of California, San Francisco (B.O.).
Abstract
BACKGROUND: We conducted the first-of-its kind randomized stroke trial in Africa to test whether a THRIVES (Tailored Hospital-based Risk reduction to Impede Vascular Events after Stroke) intervention improved blood pressure (BP) control among patients with stroke. METHODS AND RESULTS: Intervention comprised a patient global risk factor control report card, personalized phone text-messaging, and educational video. Four hundred patients recruited from 4 distinct medical facilities in Nigeria, aged ≥18 years with stroke-onset within one-year, were randomized to THRIVES intervention and control group. The control group also received text messages, and both groups received modest financial incentives. The primary outcome was mean change in systolic BP (SBP) at 12 months. There were 36.5% females, 72.3% with ischemic stroke; mean age was 57.2±11.7 years; 93.5% had hypertension and mean SBP was 138.33 (23.64) mm Hg. At 12 months, there was no significant difference in SBP reduction from baseline in the THRIVES versus control group (2.32 versus 2.01 mm Hg, P=0.82). In an exploratory analysis of subjects with baseline BP >140/90 mm Hg (n=168), THRIVES showed a significant mean SBP (diastolic BP) decrease of 11.7 (7.0) mm Hg while control group showed a significant mean SBP (diastolic BP) decrease of 11.2 (7.9) mm Hg at 12 months. CONCLUSIONS: THRIVES intervention did not significantly reduce SBP compared with controls. However, there was similar significant decrease in mean BP in both treatment arms in the subgroup with baseline hypertension. As text-messaging and a modest financial incentive were the common elements between both treatment arms, further research is required to establish whether these measures alone can improve BP control among stroke survivors. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01900756.
RCT Entities:
BACKGROUND: We conducted the first-of-its kind randomized stroke trial in Africa to test whether a THRIVES (Tailored Hospital-based Risk reduction to Impede Vascular Events after Stroke) intervention improved blood pressure (BP) control among patients with stroke. METHODS AND RESULTS: Intervention comprised a patient global risk factor control report card, personalized phone text-messaging, and educational video. Four hundred patients recruited from 4 distinct medical facilities in Nigeria, aged ≥18 years with stroke-onset within one-year, were randomized to THRIVES intervention and control group. The control group also received text messages, and both groups received modest financial incentives. The primary outcome was mean change in systolic BP (SBP) at 12 months. There were 36.5% females, 72.3% with ischemic stroke; mean age was 57.2±11.7 years; 93.5% had hypertension and mean SBP was 138.33 (23.64) mm Hg. At 12 months, there was no significant difference in SBP reduction from baseline in the THRIVES versus control group (2.32 versus 2.01 mm Hg, P=0.82). In an exploratory analysis of subjects with baseline BP >140/90 mm Hg (n=168), THRIVES showed a significant mean SBP (diastolic BP) decrease of 11.7 (7.0) mm Hg while control group showed a significant mean SBP (diastolic BP) decrease of 11.2 (7.9) mm Hg at 12 months. CONCLUSIONS: THRIVES intervention did not significantly reduce SBP compared with controls. However, there was similar significant decrease in mean BP in both treatment arms in the subgroup with baseline hypertension. As text-messaging and a modest financial incentive were the common elements between both treatment arms, further research is required to establish whether these measures alone can improve BP control among stroke survivors. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01900756.
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