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Cardiovascular medicine
Protocol
Person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood: a study protocol for a hybrid randomised controlled trial (STEPSTONES project)
  1. Mariela Acuña Mora1,2,
  2. Carina Sparud-Lundin1,
  3. Ewa-Lena Bratt1,3,
  4. Philip Moons1,2
  1. 1Institute of Health and Care Sciences, University of Gothenburg, Gothenburg, Sweden
  2. 2Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium
  3. 3Department of Pediatric Cardiology, The Queen Silvia Children's Hospital, Gothenburg, Sweden
  1. Correspondence to Professor Philip Moons; philip.moons{at}kuleuven.be

Abstract

Introduction When a young person grows up, they evolve from an independent child to an empowered adult. If an individual has a chronic condition, this additional burden may hamper adequate development and independence. Transition programmes for young persons with chronic disorders aim to provide the necessary skills for self-management and participation in care. However, strong evidence on the effects of these interventions is lacking. Therefore, as part of the STEPSTONES project (Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS), we propose a trial to assess the effectiveness of a structured, person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood.

Methods/design STEPSTONES will use a hybrid experimental design in which a randomised controlled trial is embedded in a longitudinal, observational study. It will be conducted in 4 paediatric cardiology centres in Sweden. 2 centres will be allocated to the randomised controlled trial group, assigning patients randomly to the intervention group (n=63) or the comparison group (n=63). The other 2 centres will form the intervention-naïve control group (n=63). The primary outcome is the level of patient empowerment, as measured by the Gothenburg Young Persons Empowerment Scale (GYPES).

Ethics and dissemination The study has been approved by the Regional Ethical Board of Gothenburg, Sweden. Findings will be reported following the CONSORT statement and disseminated at international conferences and as published papers in peer-reviewed journals.

Trial registration number NCT02675361; pre-results.

  • Adolescents
  • Heart defect
  • Person centered care
  • Randomized controlled trial
  • Transition

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2016-014593

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    Footnotes

    • Funding This study is supported by research grants from the Swedish Heart-Lung Foundation (grant 20150535); Swedish Research Council for Health, Working Life and Welfare-FORTE (grant STYA-2015/0003); Swedish Children Heart Association; Swedish Research Council (grant 2015-02503); and the Institute of Health and Care Sciences of the University of Gothenburg.

    • Competing interests None declared.

    • Ethics approval The study was approved by the Regional Ethical Board of Gothenburg, Sweden (No.931-15).

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

    • Data sharing statement Preliminary data on the psychometric properties of the GYPES and the LAS for parental uncertainty are on file. They will be integrated in a separate article on the psychometric evaluation of the instruments, which will be available in some months.