Mobile messaging support versus usual care for people with type 2 diabetes in sub-Saharan Africa: a protocol for a multicentre randomized controlled trial (StAR2D)

Background: Health outcomes for people treated for type 2 diabetes could be substantially improved in sub-Saharan Africa. Failure to take medicines regularly to treat diabetes has been identified as a major problem. Resources to identify and support patients who are not making best use of medicine in low and middle-income settings are scarce. Mobile phones are widely available in these settings including among people with diabetes, and linked technologies such as SMS-text messaging have shown promise in delivering low-cost interventions efficiently. However, evidence that these interventions will work when carried out at a larger scale, and of the extent to which they will improve health outcomes when added to usual care is limited. Methods: We will carry out a randomised clinical trial in two contrasting settings in sub-Saharan Africa, Cape Town in South Africa and Lilongwe in Malawi, to provide information about the impact of sending brief automated messages via SMS text-messaging. The messages will advise people about the benefits of their diabetes treatment and offer motivation and encouragement around lifestyle and use of medication. We will allocate patients using a randomly-generated assignment plan to receive either intervention messages, or an active control. We will follow up people for twelve months measuring important risk factors for poor health outcomes and complications in diabetes so we can estimate potential health benefits, including HbA1c as a marker for long-term blood glucose control and blood pressure control, We will record the costs of doing this, and estimate cost-effectiveness. We will also capture collection of medication and assess the reception of the intervention by participants and health care workers. Discussion: The knowledge gained will have wide application and advance the evidence base for effectiveness of mobile-phone based brief text-messaging on clinical outcomes and in large-scale, operational settings. It will provide evidence for cost-effectiveness that will further inform policy development and decision-making. We will work with a wide network that includes patients, clinicians, academics, industry, and policy makers to help us identify opportunities for informing people about the work and raise awareness of what is being developed and studied. Trial Registration: ISRCTN70768808 (Registered on 3 August 2015