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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Phone-based Intervention under Nurse Guidance after Stroke (PINGS): study protocol for a randomized controlled trial

Authors: Fred Stephen Sarfo, Frank Treiber, Carolyn Jenkins, Sachin Patel, Mulugeta Gebregziabher, Arti Singh, Osei Sarfo-Kantanka, Raelle Saulson, Lambert Appiah, Eunice Oparebea, Bruce Ovbiagele

Published in: Trials | Issue 1/2016

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Abstract

Background

Hypertension is the premier modifiable risk factor for recurrent stroke. In sub-Saharan Africa (SSA) where the stroke burden is escalating, little is known about the role of behavioral interventions in enhancing blood pressure (BP) control after stroke.
Our objective is to test whether an m-Health technology-enabled, nurse-led, multilevel integrated approach is effective in improving BP control among Ghanaian stroke patients within 1 month of symptom onset compared with standard of care.

Methods

This two-arm cluster randomized controlled feasibility pilot trial will involve 60 recent-stroke survivors. Using a computer-generated sequence, patients will be randomly allocated into four clusters of 15 patients each per physician: two clusters in the intervention arm and two in the control arm. Patients in the intervention arm will receive a simple pillbox, a Blue-toothed UA-767Plus BT BP device and smartphone for monitoring and reporting BP measurements and medication intake under nurse guidance for 3 months. Tailored motivational text messages will be delivered based upon levels of adherence to the medication intake. Both groups will be followed up for 6 months to compare BP control at months 3, 6 and 9 as primary outcome measure. Physicians assessing BP control will be blinded to arms into which patients are allocated. Secondary outcome measures will include medication adherence scores and Competence and Autonomous Self-regulation Scale scores. A qualitative study is planned after follow-up to explore the lived experiences of participants in the intervention arm.

Discussion

A feasible and preliminarily effective intervention would lead to a larger more definitive efficacy/effectiveness randomized controlled trial powered to look at clinical events, with the potential to reduce stroke-related morbidity and mortality in a low- to middle-income country.

Trial registration

ClinicalTrials.gov Identifier: NCT02568137, registered on 13 July 2015.
Appendix
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Metadata
Title
Phone-based Intervention under Nurse Guidance after Stroke (PINGS): study protocol for a randomized controlled trial
Authors
Fred Stephen Sarfo
Frank Treiber
Carolyn Jenkins
Sachin Patel
Mulugeta Gebregziabher
Arti Singh
Osei Sarfo-Kantanka
Raelle Saulson
Lambert Appiah
Eunice Oparebea
Bruce Ovbiagele
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1557-0

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