Abstract
BackgroundStroke is a major cause of morbidity and mortality, especially in low and middle income countries. Medical management is the mainstay of therapy to prevent recurrence of stroke. Current estimates are that only 1 in 6 patients have perfect adherence to medication schedules. Using SMS (Short Messaging Service) as reminders to take medicines have been used previously for diseases such as diabetes and HIV with moderate success. We aim to explore the effectiveness and acceptability of SMS in increasing adherence to medications in patients with stroke.MethodsThis will be a randomized, controlled, assessor blinded single center superiority trial. Adult participants with access to a cell phone and a history of stroke longer than 1 month on multiple risk modifying medications will be selected from Neurology and Stroke Clinic. They will be randomized into two parallel groups in a 1:1 ratio via block technique with one group receiving the standard of care as per institutional guidelines while the parallel group receiving SMS reminders for each dose of medicine in addition to the standard of care. In addition intervention group will receive messages for lifestyle changes, medication information, risk factors and motivation for medication adherence. These will bemodeled on Social Cognitive Theory and Health Belief Model and will be categorized by Michies Taxonomy of Behavioral Change Communication. Patient compliance to medicines will be measured at baseline and then after 2 months in each group by using the Morisky Medication Adherence Scale. The change in compliance to medication regimen after the intervention and the difference between the two groups will be used to determine the effectiveness of SMS reminders as a tool to increase medication compliance. The acceptability of the SMS will be determined by a tool designed for this study whose attributes are based Rogers Diffusion of innovation theory.A sample size of 86 participants in each arm will be sufficient to detect a difference of 1 point on the MMAS with a power of 90 % and significance level of 5 % between the two groups; using an attrition rate of 15 %, 200 participants in all will be randomized.DiscussionThe SMS for Stroke Study will provide evidence for feasibility and effectiveness of SMS in improving post stroke medication adherence in an LMIC setting.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT01986023 11 /11/2013Electronic supplementary materialThe online version of this article (doi:10.1186/s12883-015-0413-2) contains supplementary material, which is available to authorized users.
Highlights
Stroke is a major cause of morbidity and mortality, especially in low and middle income countries
Stroke is a major cause of death and disability worldwide that affects 16 million persons annually [1]
Predictors include diabetes mellitus, atrial fibrillation, large artery atherosclerosis and ischemic heart disease [10,11,12,13,14], all of which are modifiable through medical management
Summary
Stroke is a major cause of morbidity and mortality, especially in low and middle income countries. Medical management is the mainstay of therapy to prevent recurrence of stroke. We aim to explore the effectiveness and acceptability of SMS in increasing adherence to medications in patients with stroke. The burden is especially high in low and middle income countries which account for more than 85 % of all stroke related mortality [2, 3]. Long term mortality due to stroke is most frequently related to cardiovascular disease (cerebrovascular or heart disease) [8, 9]. Predictors include diabetes mellitus, atrial fibrillation, large artery atherosclerosis and ischemic heart disease [10,11,12,13,14], all of which are modifiable through medical management. For medical management to be effective compliance to medication schedule is the single most important factor
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