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RCT·pediatrics, endocrinology, clinical trial, internal medicine, pediatric ophthalmology·PMC10174028

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

BMJ Open · 17 authors, 25 centres

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TL;DR

The trial will measure whether the intervention improves diabetes self-efficacy compared to usual care.

Full summary

701 CHARS

The study plans to randomise 183 adolescents aged 17-18 to the intervention or usual care. The KiT intervention delivers tailored support via text messages over 12 months based on a readiness assessment. The primary outcome is self-efficacy for diabetes self-management at 12 months, measured with a validated scale. Secondary outcomes, measured at 6 and 12 months, include transition readiness, stigma, glycaemic control (HbA1c), healthcare utilisation, and cost. The analysis will be intention-to-treat. A key strength is the co-design of the intervention with patients and providers. A noted limitation is that participants and investigators will be unblinded due to the nature of the intervention.

STUDY TYPE

RCT

SPECIALTY

pediatrics

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10174028

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

BMJ Open

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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 .

CITATION EXPORT

Geetha Sanmugalingham, Elise Mok, Joseph A Cafazzo et al.. 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. BMJ Open. (2023). https://doi.org/10.1136/bmjopen-2022-071396

AUTHORS

17 · 25 CENTRES

Geetha Sanmugalingham, Elise Mok, Joseph A Cafazzo, Laura Desveaux, Anne-Sophie Brazeau, Gillian L Booth, Marley Greenberg, Jessica Kichler, Valeria E Rac, Peter Austin, Ellen Goldbloom, Mélanie Henderson, Alanna Landry, Ian Zenlea, Madison Taylor, Meranda Nakhla, Rayzel Shulman

1SickKids Research Institute, Toronto, Ontario, Canada
2Research Institute of the McGill University Health Centre, Montreal, QC, Canada
3Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada
4Centre for Digital Therapeutics, Techna Institute, University Health Network, Toronto, ON, Canada
5Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON, Canada
6Department of Computer Science, University of Toronto, Toronto, ON, Canada
7Institute for Better Health, Trillium Health Partners, Mississauga, ON, Canada
8Women's College Hospital Research Institute, Toronto, ON, Canada
9School of Human Nutrition, McGill University, Montreal, QC, Canada
10ICES, Toronto, ON, Canada
11Department of Medicine, University of Toronto, Toronto, ON, Canada
12MAP Centre for Urban Health Solutions, Unity Health Toronto, Toronto, ON, Canada
13Diabetes Action Canada, Canadian Institutes for Health Research (CIHR) Strategy for Patient-Oriented Research Network in Chronic Disease, Toronto General Hospital, Toronto, ON, Canada
14Department of Philosophy, Joint Centre for Bioethics, University of Toronto, Toronto, ON, Canada
15Department of Psychology, University of Windsor, Windsor, ON, Canada
16Program for Health System and Technology Evaluation, Ted Rogers Centre for Heart Research, Toronto General Hospital Research Institute, Toronto, ON, Canada
17Division of Endocrinology, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada
18Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada
19Department of Pediatrics, University of Ottawa, Ottawa, ON, Canada
20Department of Pediatrics, Université de Montréal, Montreal, QC, Canada
21Centre de Resherche, CHU Sainte-Justine, Montreal, QC, Canada
22School of Public Health, Department of Social and preventatitve Medicine, Université de Montréal, Montreal, QC, Canada
23Oak Valley Health, Markham, ON, Canada
24Department of Pediatrics, University of Toronto, Toronto, ON, Canada
25Division of Endocrinology, The Hospital for Sick Children, Toronto, ON, Canada