Text message-based intervention, Keeping in Touch (KiT), to support youth as they transition to adult type 1 diabetes care: a protocol for a multisite randomised controlled superiority trial

Abstract

IntroductionTransition from paediatric to adult care can be challenging for youth living with type 1 diabetes (T1D), as many youth feel unprepared to transfer to adult care and are at high risk for deterioration of glycaemic management and acute complications. Existing strategies to improve transition experience and outcomes are limited by cost, scalability, generalisability and youth engagement. Text messaging is an acceptable, accessible and cost-effective way of engaging youth. Together with adolescents and emerging adults and paediatric and adult T1D providers, we co-designed a text message-based intervention, Keeping in Touch (KiT), to deliver tailored transition support. Our primary objective is to test the effectiveness of KiT on diabetes self-efficacy in a randomised controlled trial.Methods and analysisWe will randomise 183 adolescents with T1D aged 17–18 years within 4 months of their final paediatric diabetes visit to the intervention or usual care. KiT will deliver tailored T1D transition support via text messages over 12 months based on a transition readiness assessment. The primary outcome, self-efficacy for diabetes self-management, will be measured 12 months after enrolment. Secondary outcomes, measured at 6 and 12 months, include transition readiness, perceived T1D-related stigma, time between final paediatric and first adult diabetes visits, haemoglobin A1c, and other glycaemia measures (for continuous glucose monitor users), diabetes-related hospitalisations and emergency department visits and the cost of implementing the intervention. The analysis will be intention-to-treat comparing diabetes self-efficacy at 12 months between groups. A process evaluation will be conducted to identify elements of the intervention and individual-level factors influencing implementation and outcomes.Ethics and disseminationThe study protocol version 7 July 2022 and accompanying documents were approved by Clinical Trials Ontario (Project ID: 3986) and the McGill University Health Centre (MP-37-2023-8823). Study findings will be presented at scientific conferences and in peer-reviewed publications.Trial registration numberNCT05434754.

Understanding Whether and How a Digital Health Intervention Improves Transition Care for Emerging Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Realist Evaluation

“…The KiT intervention [ 20 ] was developed using a user-centered design approach that engaged adolescents and emerging adults living with T1D as well as adult and pediatric diabetes providers. Specific intervention content was informed by clinician consultation and an environmental scan of diabetes transition resources mapped to domains of the “readiness of emerging adults with diabetes diagnosed in youth” (READDY) tool with the aim of improving the transition experiences among emerging adults living with T1D ( Textbox 1 ).…”

“…Strategies to improve the transition process have been implemented at the patient, provider, and service levels [16,17], but are often institution-specific or resource-intensive, thereby limiting their accessibility, scalability, and generalizability [18][19][20]. Digital health interventions are increasingly used to address these limitations while also leveraging the high prevalence of smartphone use among youth [21].…”