Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: a lifelong approach to promote effective self-management in adults with type 1 diabetes
Debbie Cooke,
Lucy Yardley,
Jackie Elliott,
Cindy Cooper,
Tim Chater,
Elizabeth Coates,
Susan Michie,
Nikki Totton,
Alan Brennan,
Fabiana Lorencatto,
Pratik Choudhary,
Nicole De Zoysa,
Simon Heller,
Paul Chadwick,
David Hopkins,
Wendy Baird,
Jane Speight,
Julia Lawton,
José Schutter,
Daniel John Pollard,
Stephanie Amiel,
Carla Gianfrancesco,
Carolin Taylor,
David Rankin,
Gill Thompson,
Elaine Scott,
Liz Cross,
Michael Joseph Campbell,
Elizabeth Cross,
Mohammed Benaissa,
Mohammad Eissa,
Tim Good,
Zheng Hui,
Stephanie Stanton-Fay,
Gillian Thompson,
Aleksandr Zaitcev,
Becky Brown,
Dan Pollard,
Chris Turtle,
Nicole de Zoysa
Affiliations
Debbie Cooke
Department of Diabetes, King’s College London Faculty of Life Sciences and Medicine, London, UK
Lucy Yardley
professor of health psychology
Jackie Elliott
Department of Oncology and Metabolism, The University of Sheffield, Sheffield, UK
Cindy Cooper
Sheffield Clinical Trials Research Unit (CTRU), Sheffield Centre for Health and Related Research, The University of Sheffield, Sheffield, UK
Tim Chater
4 Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK
Elizabeth Coates
School of Health and Related Research, The University of Sheffield, Sheffield, UK
Susan Michie
Epidemiology and Public Health, UCL, London, UK
Nikki Totton
School of Health and Related Research, The University of Sheffield, Sheffield, UK
Alan Brennan
School of Medicine and Population Health, University of Sheffield, Sheffield, UK
Fabiana Lorencatto
Centre for Behaviour Change, University College London, London, UK
Pratik Choudhary
3 Diabetes Research Centre, University of Leicester, Leicester, UK
Nicole De Zoysa
3 Department of Diabetes, King’s College Hospital NHS Foundation Trust, London, UK
Simon Heller
Department of Oncology and Metabolism, The University of Sheffield, Sheffield, UK
Paul Chadwick
Epidemiology and Public Health, UCL, London, UK
David Hopkins
General and Emergency Medicine, King’s College London, London, UK
Wendy Baird
School of Health and Related Research, The University of Sheffield, Sheffield, UK
Jane Speight
The Australian Centre for Behavioural Research in Diabetes, Melbourne, Victoria, Australia
Julia Lawton
University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, UK
José Schutter
ScHARR, University of Sheffield, Sheffield, UK
Daniel John Pollard
School of Health and Related Research, The University of Sheffield, Sheffield, UK
Stephanie Amiel
Department of Diabetes, King’s College London Faculty of Life Sciences and Medicine, London, UK
Carla Gianfrancesco
Diabetes Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
Carolin Taylor
Diabetes Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
David Rankin
Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK
Gill Thompson
Elaine Scott
1Public Health Section, School of Health and Related Research, University of Sheffield, Sheffield, UK
Liz Cross
Michael Joseph Campbell
School of Health and Related Research, The University of Sheffield, Sheffield, UK
Elizabeth Cross
School of Health and Related Research, The University of Sheffield, Sheffield, UK
Mohammed Benaissa
Department of Electronic and Electrical Engineering, University of Sheffield, Sheffield, UK
Mohammad Eissa
Department of Electronic and Electrical Engineering, University of Sheffield, Sheffield, UK
Tim Good
Department of Electronic and Electrical Engineering, University of Sheffield, Sheffield, UK
Zheng Hui
Department of Electronic and Electrical Engineering, University of Sheffield, Sheffield, UK
Stephanie Stanton-Fay
Epidemiology and Public Health, UCL, London, UK
Gillian Thompson
Northumbria Healthcare NHS Foundation Trust, North Shields, UK
Aleksandr Zaitcev
Department of Electronic and Electrical Engineering, University of Sheffield, Sheffield, UK
Introduction The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment For Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short term (manifest by falls in glycated haemoglobin, HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behavioural change techniques, technology and longer-term structured support from healthcare professionals (HCPs).Methods and analysis A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in National Health Service secondary care hospitals in the UK. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation.Ethics and dissemination Ethics approval was granted by South West-Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14 May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals.Trial registration number ISRCTN42908016.
