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Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol
  1. Anna Lena Brorsson1,2,
  2. Ewa-Lena Bratt3,4,
  3. Philip Moons3,5,
  4. Anna Ek6,7,
  5. Elisabeth Jelleryd7,
  6. Torun Torbjörnsdotter7,
  7. Carina Sparud-Lundin2,3
  1. 1Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden
  2. 2Gothenburg Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden
  3. 3Institute of Health and Care Sciences, University of Gothenburg, Gothenburg, Sweden
  4. 4Department of Pediatric Cardiology, The Queen Silvia Children’s Hospital, Gothenburg, Sweden
  5. 5Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium
  6. 6Division of Pediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden
  7. 7Department of Paediatric Diabetes, Astrid Lindgren's Children’s Hospital, Karolinska University Hospital, Stockholm, Sweden
  1. Correspondence to Dr Anna Lena Brorsson; anna-lena.brorsson{at}


Introduction Adolescence is a critical period for youths with chronic conditions, when they are supposed to take over the responsibility for their health. Type 1 diabetes (T1D) is one of the most common chronic conditions in childhood and inadequate self-management increases the risk of short-term and long-term complications. There is a lack of evidence regarding the effectiveness of transition programmes. As a part of the Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS research programme, the objective of this study is to evaluate the effectiveness and experiences of different transitional care models, including a person-centred transition programme aiming to empower adolescents with T1D to become active partners in their health and care.

Methods and analysis In this randomised controlled trial, patients are recruited from two paediatric diabetes clinics at the age of 16 years. Patients are randomly assigned to either the intervention group (n=70) where they will receive usual care plus the structured transition programme, or to the control group (n=70) where they will only receive usual care. Data will be collected at 16, 17 and 18.5 years of age. In a later stage, the intervention group will be compared with adolescents in a dedicated youth clinic in a third setting. The primary outcome is patient empowerment. Secondary outcomes include generic, diabetes-specific and transfer-specific variables.

Ethics and dissemination The study has been approved by the Ethical Review Board in Stockholm (Dnr 2018/1725-31). Findings will be reported following the Consolidated Standards of Reporting Trials statement and disseminated in peer-reviewed journals and at international conferences.

Trial registration number NCT03994536

  • diabetes & endocrinology
  • medical education & training
  • paediatrics

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:

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  • Contributors CS-L, E-LB, PM and ALB designed the study. ALB and CS-L drafted the manuscript. E-LB, PM, AE, EJ and TT participated in reviewing and editing. All authors read and approved the final manuscript.

  • Funding This work was supported by the Swedish Child Diabetes Foundation (no grant number available), the Swedish Diabetes Association Research Foundation(grant DIA2018-326), Swedish Research Council for Health, Working Life and Welfare-FORTE (grant STYA-2015/0003), Swedish Research Council (grant 2015–02503), the Institute of Health and Care Sciences of the University of Gothenburg and the Gothenburg University Centre for Person-centred care (GPCC).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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