None listed
Conditions
Brief summary
The medications known as sodium-glucose co-transporter-2 inhibitors (SGLT2i) provide major benefits to important patient outcomes including a reduced likelihood of cardiovascular events or hospitalisations for heart failure, and a reduced risk of advanced kidney disease or kidney failure, in addition to helping to prevent or manage diabetes, to lower blood pressure, and to facilitate weight loss. Despite their many benefits, at least a third of people discontinue taking these agents within 12 months. Stakeholder engagement and external research suggests that improving patient education about the many benefits of the agents, teaching strategies to prevent side effects and providing advice about ways to remember to take medications consistently could significantly boost adherence. Text messaging provides an innovative way to deliver education and support using ubiquitous technology, and text message interventions have been used to significantly improve adherence for people with other chronic diseases. The TEXT-STIMULI trial is a randomised control trial which investigates the effectiveness of a text messaging program to improve adherence to SGLT2i, while simultaneously assessing the feasibility of implementing the intervention on a wider scale.
Interventions
The intervention is mobile phone text messages received by participants in addition to standard of care for 12 months. Participants randomised to the intervention group will receive regular mobile phone text messages containing educational and motivational content and/or medication adherence reminders. These may include delivery of infographic factsheets or animated videos which have been developed for the purposes of this study or published online factsheets by The Baker Heart and Diabetes Inst
The intervention is mobile phone text messages received by participants in addition to standard of care for 12 months. Participants randomised to the intervention group will receive regular mobile phone text messages containing educational and motivational content and/or medication adherence reminders. These may include delivery of infographic factsheets or animated videos which have been developed for the purposes of this study or published online factsheets by The Baker Heart and Diabetes Institute, an independent Australian-based research institute producing evidence-based resources by experts, for use by clients and health professionals for patient education At week 4, participants within the intervention group will be randomised (1:1) to receive a set program (TEXT-S) of 3 messages per week, or a personalised program (TEXT-P), which will allow participants to choose a text message frequency ranging from 2 to 4 messages per week. The text-messages will be delivered automatically via the TEXTCARE platform. The delivery of text messages will not be monitored via the platform, however, checks by the central study coordinator to ensure participants are receiving the text messages as designed may be incorporated. All responses from participants to any automatic messages received by the TEXTCARE platform will be monitored.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
An indication for SGLT2 Inhibitor (as per Australian and Canadian guidelines at time of assessment). Receiving a first, and ongoing, prescription for an SGLT2 Inhibitor. Access to an operational smart mobile telephone that can send and receive text messages, open multimedia files, and access the Internet. Sufficient English language proficiency to read and understand text messages on a mobile telephone. Willing and able to perform trial related procedures.
Exclusion criteria
Life expectancy less than 12 months. Already prescribed an SGLT2i more than 3 months prior to assessment. Diagnosed with Type 1 diabetes mellitus or gestational diabetes.
Outcome results
None listed