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

Ruoxi Wang; Geneviève Rouleau; Gillian Lynn Booth; Anne-Sophie Brazeau; Noor El-Dassouki; Madison Taylor; Joseph A Cafazzo; Marley Greenberg; Meranda Nakhla; Rayzel Shulman; Laura Desveaux

doi:10.2196/46115

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

JMIR Res Protoc. 2023 Sep 13:12:e46115. doi: 10.2196/46115.

Authors

Ruoxi Wang¹, Geneviève Rouleau^{2

3

4}, Gillian Lynn Booth^{5

6

7}, Anne-Sophie Brazeau⁸, Noor El-Dassouki⁹, Madison Taylor⁹, Joseph A Cafazzo^{7

9

10

11}, Marley Greenberg^{12

13}, Meranda Nakhla^{14

15}, Rayzel Shulman^#^{7

16

17

18}, Laura Desveaux^#^{1

7}

Affiliations

¹ Institute for Better Health, Trillium Health Partners, Mississauga, ON, Canada.
² Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.
³ Département des Sciences Infirmières, Université du Québec en Outaouais, St-Jérôme, QC, Canada.
⁴ Faculté des sciences infirmières, l'Université de Montréal, Montreal, QC, Canada.
⁵ MAP Centre for Urban Health Solutions, Unity Health Toronto, Toronto, ON, Canada.
⁶ Department of Medicine, University of Toronto, Toronto, ON, Canada.
⁷ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
⁸ School of Human Nutrition, McGill University, Montréal, QC, Canada.
⁹ Centre for Digital Therapeutics, Toronto General Hospital, University Health Network, Toronto, ON, Canada.
¹⁰ Institute of Biomedical Engineering, University of Toronto, Toronto, ON, Canada.
¹¹ Department of Computer Science, University of Toronto, Toronto, ON, Canada.
¹² Department of Philosophy, Joint Centre for Bioethics, University of Toronto, Toronto, ON, Canada.
¹³ Diabetes Action Canada, Toronto, ON, Canada.
¹⁴ Division of Endocrinology, Montreal Children's Hospital, McGill University, Montréal, QC, Canada.
¹⁵ Research Institute of the McGill University Health Centre, Montréal, QC, Canada.
¹⁶ Child Health Evaluative Sciences, SickKids Research Institute, Toronto, ON, Canada.
¹⁷ Division of Endocrinology, The Hospital for Sick Children, Toronto, ON, Canada.
¹⁸ Department of Pediatrics, University of Toronto, Toronto, ON, Canada.

^# Contributed equally.

PMID: 37703070
PMCID: PMC10534286
DOI: 10.2196/46115

Abstract

Background: Emerging adults living with type 1 diabetes (T1D) face a series of challenges with self-management and decreased health system engagement, leading to an increased risk of acute complications and hospital admissions. Effective and scalable strategies are needed to support this population to transfer seamlessly from pediatric to adult care with sufficient self-management capability. While digital health interventions for T1D self-management are a promising strategy, it remains unclear which elements work, how, and for which groups of individuals.

Objective: This study aims to evaluate the design and implementation of a multicomponent SMS text message-based digital health intervention to support emerging adults living with T1D in real-world settings. The objectives are to identify the intervention components and associated mechanisms that support user engagement and T1D health care transition experiences and determine the individual characteristics that influence the implementation process.

Methods: We used a realist evaluation embedded alongside a randomized controlled trial, which uses a sequential mixed methods design to analyze data from multiple sources, including intervention usage data, patient-reported outcomes, and realist interviews. In step 1, we conducted a document analysis to develop a program theory that outlines the hypothesized relationships among "individual-level contextual factors, intervention components and features, mechanisms, and outcomes," with special attention paid to user engagement. Among them, intervention components and features depict 10 core characteristics such as transition support information, problem-solving information, and real-time interactivity. The proximal outcomes of interest include user engagement, self-efficacy, and negative emotions, whereas the distal outcomes of interest include transition readiness, self-blood glucose monitoring behaviors, and blood glucose. In step 2, we plan to conduct semistructured realist interviews with the randomized controlled trial's intervention-arm participants to test the hypothesized "context-intervention-mechanism-outcome" configurations. In step 3, we plan to triangulate all sources of data using a coincidence analysis to identify the necessary combinations of factors that determine whether and how the desired outcomes are achieved and use these insights to consolidate the program theory.

Results: For step 1 analysis, we have developed the initial program theory and the corresponding data collection plan. For step 2 analysis, participant enrollment for the randomized controlled trial started in January 2023. Participant enrollment for this realist evaluation was anticipated to start in July 2023 and continue until we reached thematic saturation or achieved informational power.

Conclusions: Beyond contributing to knowledge on the multiple pathways that lead to successful engagement with a digital health intervention as well as target outcomes in T1D care transitions, embedding the realist evaluation alongside the trial may inform real-time intervention refinement to improve user engagement and transition experiences. The knowledge gained from this study may inform the design, implementation, and evaluation of future digital health interventions that aim to improve transition experiences.

International registered report identifier (irrid): PRR1-10.2196/46115.

Keywords: digital health; emerging adults; realist evaluation; self-management; transition to adult care; type 1 diabetes.

©Ruoxi Wang, Geneviève Rouleau, Gillian Lynn Booth, Anne-Sophie Brazeau, Noor El-Dassouki, Madison Taylor, Joseph A Cafazzo, Marley Greenberg, Meranda Nakhla, Rayzel Shulman, Laura Desveaux. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.09.2023.