PINGS (Phone-Based Intervention Under Nurse Guidance After Stroke): Interim Results of a Pilot Randomized Controlled Trial
Fred Sarfo, Frank Treiber, Mulugeta Gebregziabher, Sheila Adamu, Sachin Patel, Michelle Nichols, Dominic Awuah, Asumadu Sakyi, Nyantakyi Adu-Darko, Arti Singh, Raelle Tagge, Jenkins Carolyn, Bruce Ovbiagele, Fred Sarfo, Frank Treiber, Mulugeta Gebregziabher, Sheila Adamu, Sachin Patel, Michelle Nichols, Dominic Awuah, Asumadu Sakyi, Nyantakyi Adu-Darko, Arti Singh, Raelle Tagge, Jenkins Carolyn, Bruce Ovbiagele
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.
Keywords: blood pressure; hypertension; medication adherence; randomized controlled trial; survivors.
Conflict of interest statement
Conflicts of Interest: None for all authors
© 2017 American Heart Association, Inc.
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Source: PubMed