Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial

Abstract

BackgroundInterventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care.Methods/designThe SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data are collected on non-participants.DiscussionThe StAR trial uses a novel, low cost system based on widely available mobile phone technology to deliver the SMS-based intervention, manage communication with patients, and measure clinically relevant outcomes. The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting.Trial registrationNCT02019823

From Theory-Inspired to Theory-Based Interventions: A Protocol for Developing and Testing a Methodology for Linking Behaviour Change Techniques to Theoretical Mechanisms of Action

“…BCTTv1 has been used to code interventions across a variety of behavioural domains, including physical activity and dietary behaviours [31,32], oral hygiene behaviours [33], hazardous and harmful drinking [34], sexual health behaviours [35][36][37], blood pressure control/management behaviours [38], antibiotic-prescribing [39,40] and diabetes preventative behaviours [41]. BCTTv1 has also been used by systematic reviewers to identify BCTs within intervention papers, in order to facilitate intervention comparison and evaluate technique efficacy (e.g.…”

Exploring User Acceptance of a Text-message Base Health Intervention among Young African Americans

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Text Messaging and Patient Engagement in an Increasingly Mobile World

“…11 The content of the messages was largely advice, providing information about pillboxes, appointment reminders, or medication side effects. 11 In contrast, the interactive texting arm included texts from this bank but also asked participants to respond in a return text to an automated system.…”