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

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

doi:10.1136/bmjopen-2022-071396

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 May 8;13(5):e071396. doi: 10.1136/bmjopen-2022-071396.

Authors

Geetha Sanmugalingham¹, Elise Mok², Joseph A Cafazzo^{3

4

5

6}, Laura Desveaux^{3

7

8}, Anne-Sophie Brazeau⁹, Gillian L Booth^{3

10

11

12}, Marley Greenberg^{13

14}, Jessica Kichler¹⁵, Valeria E Rac^{3

16}, Peter Austin^{3

10}, Ellen Goldbloom^{17

18

19}, Mélanie Henderson^{20

21

22}, Alanna Landry²³, Ian Zenlea^{3

7

24}, Madison Taylor⁴, Meranda Nakhla², Rayzel Shulman^{25

3

10

24

26}

Affiliations

¹ SickKids Research Institute, Toronto, Ontario, Canada.
² Research Institute of the McGill University Health Centre, Montreal, QC, Canada.
³ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
⁴ Centre for Digital Therapeutics, Techna Institute, University Health Network, Toronto, ON, Canada.
⁵ Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON, Canada.
⁶ Department of Computer Science, University of Toronto, Toronto, ON, Canada.
⁷ Institute for Better Health, Trillium Health Partners, Mississauga, ON, Canada.
⁸ Women's College Hospital Research Institute, Toronto, ON, Canada.
⁹ School of Human Nutrition, McGill University, Montreal, QC, Canada.
¹⁰ ICES, Toronto, ON, Canada.
¹¹ Department of Medicine, University of Toronto, Toronto, ON, Canada.
¹² MAP Centre for Urban Health Solutions, Unity Health Toronto, Toronto, ON, Canada.
¹³ Diabetes Action Canada, Canadian Institutes for Health Research (CIHR) Strategy for Patient-Oriented Research Network in Chronic Disease, Toronto General Hospital, Toronto, ON, Canada.
¹⁴ Department of Philosophy, Joint Centre for Bioethics, University of Toronto, Toronto, ON, Canada.
¹⁵ Department of Psychology, University of Windsor, Windsor, ON, Canada.
¹⁶ Program for Health System and Technology Evaluation, Ted Rogers Centre for Heart Research, Toronto General Hospital Research Institute, Toronto, ON, Canada.
¹⁷ Division of Endocrinology, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
¹⁸ Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada.
¹⁹ Department of Pediatrics, University of Ottawa, Ottawa, ON, Canada.
²⁰ Department of Pediatrics, Université de Montréal, Montreal, QC, Canada.
²¹ Centre de Resherche, CHU Sainte-Justine, Montreal, QC, Canada.
²² School of Public Health, Department of Social and preventatitve Medicine, Université de Montréal, Montreal, QC, Canada.
²³ Oak Valley Health, Markham, ON, Canada.
²⁴ Department of Pediatrics, University of Toronto, Toronto, ON, Canada.
²⁵ SickKids Research Institute, Toronto, Ontario, Canada rayzel.shulman@sickkids.ca.
²⁶ Division of Endocrinology, The Hospital for Sick Children, Toronto, ON, Canada.

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.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Adult
Blood Glucose
Child
Diabetes Mellitus, Type 1* / therapy
Humans
Randomized Controlled Trials as Topic
Self Care
Text Messaging*
Transition to Adult Care*

Substances

Blood Glucose

Associated data

ClinicalTrials.gov/NCT05434754

Grants and funding

423967/CIHR/Canada