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

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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.

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-016-1557-0) contains supplementary material, which is available to authorized users.

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Most cited references 46

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The Discovery of Grounded Theory

Barney G. Glaser, Anselm L. Strauss (1967)

Most writing on sociological method has been concerned with how accurate facts can be obtained and how theory can thereby be more rigorously tested. In The Discovery of Grounded Theory, Barney Glaser and Anselm Strauss address the equally Important enterprise of how the discovery of theory from data--systematically obtained and analyzed in social research--can be furthered. The discovery of theory from data--grounded theory--is a major task confronting sociology, for such a theory fits empirical situations, and is understandable to sociologists and laymen alike. Most important, it provides relevant predictions, explanations, interpretations, and applications.In Part I of the book, Generation Theory by Comparative Analysis, the authors present a strategy whereby sociologists can facilitate the discovery of grounded theory, both substantive and formal. This strategy involves the systematic choice and study of several comparison groups. In Part II, The Flexible Use of Data, the generation of theory from qualitative, especially documentary, and quantitative data Is considered. In Part III, Implications of Grounded Theory, Glaser and Strauss examine the credibility of grounded theory.The Discovery of Grounded Theory is directed toward improving social scientists' capacity for generating theory that will be relevant to their research. While aimed primarily at sociologists, it will be useful to anyone Interested In studying social phenomena--political, educational, economic, industrial-- especially If their studies are based on qualitative data.

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Brief questions to identify patients with inadequate health literacy.

Lisa Chew, Katharine A Bradley, Edward Boyko (2004)

No practical method for identifying patients with low heath literacy exists. We sought to develop screening questions for identifying patients with inadequate or marginal health literacy. Patients (n=332) at a VA preoperative clinic completed in-person interviews that included 16 health literacy screening questions on a 5-point Likert scale, followed by a validated health literacy measure, the Short Test of Functional Health Literacy in Adults (STOHFLA). Based on the STOFHLA, patients were classified as having either inadequate, marginal, or adequate health literacy. Each of the 16 screening questions was evaluated and compared to two comparison standards: (1) inadequate health literacy and (2) inadequate or marginal health literacy on the STOHFLA. Fifteen participants (4.5%) had inadequate health literacy and 25 (7.5%) had marginal health literacy on the STOHFLA. Three of the screening questions, "How often do you have someone help you read hospital materials?" "How confident are you filling out medical forms by yourself?" and "How often do you have problems learning about your medical condition because of difficulty understanding written information?" were effective in detecting inadequate health literacy (area under the receiver operating characteristic curve of 0.87, 0.80, and 0.76, respectively). These questions were weaker for identifying patients with marginal health literacy. Three questions were each effective screening tests for inadequate health literacy in this population.

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Update on the Global Burden of Ischemic and Hemorrhagic Stroke in 1990-2013: The GBD 2013 Study

Valery L. Feigin, Rita V Krishnamurthi, Priya Parmar … (2015)

Background: Global stroke epidemiology is changing rapidly. Although age-standardized rates of stroke mortality have decreased worldwide in the past 2 decades, the absolute numbers of people who have a stroke every year, and live with the consequences of stroke or die from their stroke, are increasing. Regular updates on the current level of stroke burden are important for advancing our knowledge on stroke epidemiology and facilitate organization and planning of evidence-based stroke care. Objectives: This study aims to estimate incidence, prevalence, mortality, disability-adjusted life years (DALYs) and years lived with disability (YLDs) and their trends for ischemic stroke (IS) and hemorrhagic stroke (HS) for 188 countries from 1990 to 2013. Methodology: Stroke incidence, prevalence, mortality, DALYs and YLDs were estimated using all available data on mortality and stroke incidence, prevalence and excess mortality. Statistical models and country-level covariate data were employed, and all rates were age-standardized to a global population. All estimates were produced with 95% uncertainty intervals (UIs). Results: In 2013, there were globally almost 25.7 million stroke survivors (71% with IS), 6.5 million deaths from stroke (51% died from IS), 113 million DALYs due to stroke (58% due to IS) and 10.3 million new strokes (67% IS). Over the 1990-2013 period, there was a significant increase in the absolute number of DALYs due to IS, and of deaths from IS and HS, survivors and incident events for both IS and HS. The preponderance of the burden of stroke continued to reside in developing countries, comprising 75.2% of deaths from stroke and 81.0% of stroke-related DALYs. Globally, the proportional contribution of stroke-related DALYs and deaths due to stroke compared to all diseases increased from 1990 (3.54% (95% UI 3.11-4.00) and 9.66% (95% UI 8.47-10.70), respectively) to 2013 (4.62% (95% UI 4.01-5.30) and 11.75% (95% UI 10.45-13.31), respectively), but there was a diverging trend in developed and developing countries with a significant increase in DALYs and deaths in developing countries, and no measurable change in the proportional contribution of DALYs and deaths from stroke in developed countries. Conclusion: Global stroke burden continues to increase globally. More efficient stroke prevention and management strategies are urgently needed to halt and eventually reverse the stroke pandemic, while universal access to organized stroke services should be a priority.

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Author and article information

Contributors

Fred Stephen Sarfo: Stephensarfo78@gmail.com

Frank Treiber: treiberf@musc.edu

Carolyn Jenkins: jenkinsc@musc.edu

Sachin Patel: patelsk@musc.edu

Mulugeta Gebregziabher: gebregz@musc.edu

Arti Singh: artisingh_uk@yahoo.com

Osei Sarfo-Kantanka: osarfokantanka21@gmail.com

Raelle Saulson: saulson@musc.edu

Lambert Appiah: tettehappiah@gmail.com

Eunice Oparebea: oparebeansah@yahoo.com

Bruce Ovbiagele: ovibes@musc.edu

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 5 September 2016

Publication date PMC-release: 5 September 2016

Publication date Collection: 2016

Volume: 17

Issue: 1

Electronic Location Identifier: 436

Affiliations

[1 ]Division of Neurology, Department of Medicine, Kwame Nkrumah University of Science and Technology, P.M.B., Kumasi, Ghana

[2 ]Komfo Anokye Teaching Hospital, Kumasi, Ghana

[3 ]Technology Applications Center for Healthful Lifestyles, Medical University of South Carolina, South Carolina, Ghana

[4 ]Department of Nursing, Medical University of South Carolina, South Carolina, Ghana

[5 ]Department of Psychiatry, Medical University of South Carolina, South Carolina, Ghana

[6 ]Department of Public Health Sciences, Medical University of South Carolina, South Carolina, Ghana

[7 ]Department of Neurology, Medical University of South Carolina, South Carolina, Ghana

Article

Publisher ID: 1557

DOI: 10.1186/s13063-016-1557-0

PMC ID: 5011977

PubMed ID: 27596244

SO-VID: 2de8f59d-c31e-4352-a833-837917867d60

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 26 March 2016

Date accepted : 18 August 2016

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100000065, National Institute of Neurological Disorders and Stroke;

Award ID: R21 NS094033

Award Recipient : Bruce Ovbiagele

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

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Abstract

Background

Methods

Discussion

Trial registration

Electronic supplementary material

Related collections

Stroke MRI

Most cited references 46

The Discovery of Grounded Theory

Brief questions to identify patients with inadequate health literacy.

Update on the Global Burden of Ischemic and Hemorrhagic Stroke in 1990-2013: The GBD 2013 Study

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Cited by 13

Most referenced authors 1,360