Abstract
BackgroundAtherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality worldwide, with a prevalence of approximately 100 million patients. There is evidence that antiplatelet agents and antihypertensive medications could reduce the risk of new vascular events in this population; however, treatment adherence is very low. An SMS text messaging intervention was recently developed based on behavior change techniques to increase adherence to pharmacological treatment among patients with a history of ASCVD.ObjectiveThis study aims to evaluate the efficacy and safety of an SMS text messaging intervention to improve adherence to cardiovascular medications in patients with ASCVD.MethodsA randomized controlled clinical trial for patients with a prior diagnosis of cardiovascular events, such as acute myocardial infarction, unstable angina, cerebrovascular disease, or peripheral artery disease, in one center in Colombia was conducted. Patients randomized to the intervention arm were assigned to receive SMS text messages daily for the first 4 weeks, 5 SMS text messages on week 5, 3 SMS text messages each in weeks 6 and 7, and 1 SMS text message weekly from week 8 until week 52. In contrast, patients in the control arm received a monthly SMS text message reminding them of the next study appointment and the importance of the study, requesting information about changes in their phone number, and thanking them for participating in the study. The primary endpoint was the change in low-density lipoprotein cholesterol (LDL-C) levels, whereas the secondary endpoints were the changes in thromboxane B2 levels, heart rate, systolic and diastolic blood pressure, medication adherence, cardiac and noncardiac mortality, and hospitalization. Linear regression analyses and bivariate tests were performed.ResultsOf the 930 randomized patients, 805 (86.5%) completed follow-up and were analyzed for the primary endpoint. There was no evidence that the intervention changed the primary outcome (LDL-C levels; P=.41) or any of the secondary outcomes evaluated (all P>.05). There was also no evidence that the intervention was associated with adverse events.ConclusionsIn this study, there was no evidence that a behavior modification intervention delivered by SMS text messaging improved LDL-C levels, blood pressure levels, or adherence at 12 months. More research is needed to evaluate whether different SMS text messaging strategies, including personalized messages and different timings, are effective; future studies should include mixed methods to better understand why, for whom, and in which context (eg, health system or social environment) SMS text messaging interventions work (or not) to improve adherence in patients with ASCVD.Trial RegistrationClinicalTrials.gov NCT03098186; https://clinicaltrials.gov/ct2/show/NCT03098186International Registered Report Identifier (IRRID)RR2-10.1136/bmjopen-2018-028017
Highlights
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in the world
There was no difference between arms in change of Low Density Lipoprotein-Cholesterol (LDL-C) at 12 months (P=.41). or for any of the secondary outcomes
In our study we did not find evidence that a behavior modification intervention delivered by short message services (SMS) improved LDLC, blood pressure levels or adherence at 12 months
Summary
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in the world. There is evidence that antiplatelet agents and antihypertensive medication reduce the risk of new vascular events in this population, but treatment adherence is very low. Robust evidence indicates that the use of antiplatelet agents, beta blocker agents, ACE inhibitors and statins reduce the incidence of future fatal and non-fatal cardiovascular events in this population, and it is cost effective. These medications are recommended in all international guidelines for the management of people with ASCVD [4,5]. Less than half of patients with known ASCVD disease in high-income countries are receiving this group of cardiovascular medications, and the situation is much worse in Low-to-middle-Income Country (LMICs), where only 1 in 20 patients with ASCVD received all four types of cardiovascular drugs in 2011 [8]
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