Phone-Based Intervention under Nurse Guidance after Stroke (PINGS II) Study: Protocol for a Phase III Randomized Clinical Trial |
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| Authors: | Fred Stephen Sarfo Albert Akpalu Ansumana Bockarie Lambert Appiah Samuel Blay Nguah Nana Kwame Ayisi-Boateng Sheila Adamu Christiana Neizer Agnes Arthur Richard Nyamekye Kwabena Agyenim-Boateng Raelle Tagge Nathaniel Adusei-Mensah Michael Ampofo Ruth Laryea Arti Singh John Humphry Amuasi Bruce Ovbiagele |
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| Affiliation: | 2. Komfo Anokye Teaching Hospital, Kumasi, Ghana;3. University of Ghana, Accra, Ghana;4. University of Cape Coast, Cape Coast, Ghana;5. Kumasi South Hospital, Kumasi, Ghana;6. Agogo Presbyterian Hospital, Agogo, Ghana;11. Northern California Institute of Research and Education, USA;12. University of California, San Francisco, USA;2. Neuroscience Research, Allina Health, Minneapolis, MN, USA;2. Division of Neurosurgery, University Surgical Cluster, National University Health System, Singapore;2. Department of Cardiology, University of Campinas, UNICAMP, Campinas, SP, Brazil;3. Neuroimaging Laboratory, Department of Neurology, University of Campinas, UNICAMP, Campinas, SP, Brazil;4. Brazilian Institute of Neuroscience and Neurotechnology, BRAINN, at UNICAMP, Campinas, SP, Brazil;5. Department of Medical Psychology and Psychiatry, University of Campinas, UNICAMP, Campinas, SP, Brazil;2. Department of Neurosurgery, NYU Langone Medical Center, New York, New York, USA;3. Department of Epidemiology and Neurology, Columbia University Irving Medical Center, New York, New York, USA;4. Department of Neurology, Brown University School of Medicine, Providence, RI, USA;1. Department of Neurology and Suzhou Clinical Research Center of Neurological Disease, The Second Affiliated Hospital of Soochow University, Suzhou 215004, China;2. Department of Neurology, Taicang Affiliated Hospital of Soochow University, The first People''s Hospital of Taicang, Taicang 215400, China;3. Jiangsu Key Laboratory of Neuropsychiatric Diseases and Institute of Neuroscience, Soochow University, Suzhou 215123, China;1. Department of Neurosurgery, CHA Bundang Medical Center, CHA University, School of Medicine;2. College of Nursing, CHA University, 120 Haeryong-ro, Pocheon-shi, Gyeongghi-do, South Korea |
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| Abstract: | ObjectivesThe Sub-Saharan African (SSA) region now has the highest estimated effect size of hypertension for stroke causation worldwide. An urgent priority for countries in SSA is to develop and test self-management interventions to control hypertension among those at highest risk of adverse outcomes. Thus the overall objective of the Phone-based Intervention under Nurse Guidance after Stroke II study (PINGS-2) is to deploy a hybrid study design to assess the efficacy of a theoretical-model-based, mHealth technology-centered, nurse-led, multi-level integrated approach to improve longer term blood pressure (BP) control among stroke survivors.Materials and methodsA phase III randomized controlled trial involving 500 recent stroke survivors to be enrolled across 10 Ghanaian hospitals. Using a computer-generated sequence, patients will be randomly assigned 1:1 into the intervention or usual care arms. The intervention comprises of (i) home BP monitoring at least once weekly with nurse navigation for high domiciliary BP readings; (2) medication reminders using mobile phone alerts and (3) education on hypertension and stroke delivered once weekly via audio messages in preferred local dialects. The intervention will last for 12 months. The control group will receive usual care as determined by local guidelines. The primary outcome is the proportion of patients with systolic BP <140 mm Hg at 12 months. Secondary outcomes will include medication adherence, self-management of hypertension, major adverse cardiovascular events, health related quality of life and implementation outcomes.ConclusionAn effective PINGS intervention can potentially be scaled up and disseminated across healthcare systems in low-and-middle income countries challenged with resource constraints to reduce poor outcomes among stroke survivors. |
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