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

Introduction: Transition 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 analysis: We 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 dissemination: The 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 number: NCT05434754.

Keywords: adolescent; clinical trials; diabetes & endocrinology; paediatric endocrinology; patient participation; telemedicine.

Conflict of interest statement

Competing interests: RS and A-SB have received speaking fees from Dexcom. EG is the Site Co-Investigator role for Medtronic study grant to the institution and Chair of Epic® Pediatric Endocrinology Specialty Steering Board. IZ reports receiving personal fees from Abbott Diabetes Care and Novo Nordisk Canada Inc. and research funding support from the University of Toronto, Navigator Limited, the Medical Psychiatry Alliance, Regional Municipality of Peel, Community Foundation of Mississauga, Canadian Institutes of Health Research (CIHR), and Social Sciences and Humanities Research Council of Canada (SSHRC). MH is recipient of the 2019 Canadian Society of Endocrinology and Metabolism’s Young Investigator Award, and a FRQS Senior salary award. Her research has been funded by the Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Diabète Québec and Fonds de recherche en Santé du québec (FRQS).

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.