Development and evaluation of a digital health intervention to prevent type 2 diabetes mellitus in a primary care: Study protocol for the PREDIABETXT randomised clinical trial

Abstract

type 2 diabetes mellitus (T2DM) based on: i) the use of a system comprising mobile health (mHealth) technology integrated with electronic health records to send tailored text messages (SMSs) promoting lifestyle changes in people at risk of T2DM, and, ii) the provision of online education to primary healthcare workers about prediabetes management. Design: The PREDIABETEXT project is a controlled, parallel, three-arm, cluster randomized trial and involve five phases. Methods: In phases 1-4 we will develop and pilot-test the different components of the intervention (In phase 1 we will develop the brief text messages targeted to patients; In phase 2 we will adapt our existing technology system to deliver the messages; In phase 3 we will develop an educational intervention targeted to Primary Care workers, and; In phase 4 we will pilot-test and optimise both interventions). In phase 5 we will conduct a phase II, six-month, three-arm, cluster randomised, clinical trial with 42 primary care workers and 420 patients at risk of T2DM (HbA1c from 6% to 6.4% or fasting plasma glucose 110-125mg/dl, or both). Patients will be allocated to a control (usual care) group, intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare workers). The primary outcome will be HbA1c. Secondary outcomes will include additional clinical, physiological, behavioural and psychological outcomes. Discussion: Recent trials suggest that digital health interventions can effectively prevent T2DM and reduce important T2DM risk factors such as overweight or hypertension. In Spain this type of interventions is understudied.