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Group education for adolescents with type 1 diabetes during transition from paediatric to adult care: study protocol for a multisite, randomised controlled, superiority trial (GET-IT-T1D)
  1. Elise Mok1,
  2. Melanie Henderson2,
  3. Kaberi Dasgupta1,
  4. Elham Rahme1,
  5. Mohammad Hajizadeh3,
  6. Lorraine Bell4,
  7. Melinda Prevost5,
  8. Jennifer Frei1,
  9. Meranda Nakhla5
  1. 1Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Montreal, Québec, Canada
  2. 2Centre de Recherche du Centre Hospitalier Universitaire Sainte-Justine, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Québec, Canada
  3. 3School of Health Administration, Dalhousie University, Halifax, Nova Scotia, Canada
  4. 4Pediatrics, Nephrology, McGill University Health Centre, Montréal, Québec, Canada
  5. 5Pediatrics, Endocrinology, McGill University Health Centre, Montreal, Québec, Canada
  1. Correspondence to Dr Meranda Nakhla; meranda.nakhla{at}mcgill.ca

Abstract

Introduction Transition from paediatric to adult care is challenging for adolescents and emerging adults (ages 18 to 30 years) with type 1 diabetes (T1D). This transition is characterised by a deterioration in glycaemic control (haemoglobin A1c (HbA1c)), decreased clinical attendance, poor self-management and increased acute T1D-related complications. However, evidence to guide delivery of transition care is lacking. Given the effectiveness of group education in adult diabetes glycaemic control and improvements in qualitative measures in paediatric diabetes, group education is a potentially feasible and cost-effective alternative for the delivery of transition care. In emerging adults with T1D, we aim to assess the effectiveness of group education visits compared with usual care on HbA1c, T1D-related complications, psychosocial measures and cost-effectiveness after the transfer to adult care.

Methods and analysis In a multisite, assessor-blinded, randomised, two-arm, parallel-group, superiority trial, 212 adolescents with T1D (ages 17 years) are randomised to 12 months group education versus usual T1D care before transfer to adult care. Visits in the active arm consist of group education sessions followed by usual T1D care visits every 3 months. Primary outcome is change in HbA1c measured at 24 months. Secondary outcomes are delays in establishing adult diabetes care, T1D-related hospitalisations and emergency department visits, severe hypoglycaemia, stigma, self-efficacy, diabetes knowledge, transition readiness, diabetes distress, quality of life and cost-effectiveness at 12 and 24 months follow-up. Analysis will be by intention-to-treat. Change in HbA1c will be calculated and compared between arms using differences (95% CI), along with cost-effectiveness analysis. A similar approach will be conducted to examine between-arm differences in secondary outcomes.

Ethics and dissemination The study was approved by McGill University Health Centre Research Ethics Board (GET-IT/MP-37-2019-4434, version ‘Final 1.0 from November 2018). Study results will be disseminated through peer-reviewed publications.

Trial registration number NCT03703440.

  • diabetes & endocrinology
  • paediatric endocrinology
  • paediatrics

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors MN (principal investigator) conceived and designed the study with input from MeH (Pediatric Endocrinologist), KD, ER (Biostatistician), MoH (Health Economist), LB, EM and MP. EM and JF helped with implementation. MN, MeH (Pediatric Endocrinologist), KD, ER, MoH (Health Economist), LB and MP are grant holders. ER provided statistical expertise in clinical trial design and is conducting the primary statistical analysis. EM drafted the initial manuscript. All authors contributed to refinement of the study protocol and approved the final manuscript.

  • Funding This work was supported by the Canadian Institutes of Health Research (CIHR) grant number PJT 156096.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The study was approved by McGill University Health Centre Research Ethics Board (GET-IT/MP-37-2019-4434, version ‘Final 1.0 from November 2018).

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

  • Data availability statement Individual participant data supporting the results reported in the published research articles, after de-identification will be available. Other documents that will be available include the study protocol, statistical analysis plan and informed consent form. The data will be available immediately following article publication and ending 5 years after article publication. Data will be shared with researchers who provide a scientifically sound proposal that has been approved by an independent Institutional Review Board and for analyses that addresses the aims specified in the proposal (e.g. for individual participant data meta-analysis). Proposals should be submitted to meranda.nakhla@mcgill.ca. Data requestors will need to sign a data access agreement. Data will be available up to 5 years following article publication at (Link to be included).

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