Phone-Based Intervention under Nurse Guidance after Stroke (PINGS II) Study: Protocol for a Phase III Randomized Clinical Trial

Autor: Michael Ampofo, Nathaniel Adusei-Mensah, Kwabena Agyenim-Boateng, Agnes Arthur, Richard King Nyamekye, Raelle Tagge, Lambert Appiah, Arti Singh, Ansumana Sandy Bockarie, Fred Stephen Sarfo, John Humphry Amuasi, Ruth Laryea, Nana Kwame Ayisi-Boateng, Albert Akpalu, Sheila Adamu, Christiana Neizer, Bruce Ovbiagele, Samuel Blay Nguah
Rok vydání: 2021
Předmět:
Zdroj: J Stroke Cerebrovasc Dis
ISSN: 1052-3057
DOI: 10.1016/j.jstrokecerebrovasdis.2021.105888
Popis: BACKGROUND: The 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. METHODS: A 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 arm. 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
Databáze: OpenAIRE