Developing and testing the DAFNEplus intervention

A lifelong approach to promote effective self-management in adults with type 1 diabetes

Principal Investigator	Professor Simon Heller, University of Sheffield
Co-investigators	Dr Judith Cohen (University of Sheffield), Professor Alan Brennan (University of Sheffield), Dr Wendy Baird (University of Sheffield), Professor Julia Lawton (University of Edinburgh), Professor Lucy Yardley (University of Southampton), Professor Mike Campbell (University of Sheffield), Dr Jackie Elliott (University of Sheffield), Mrs Gillian Thompson (Northumbria Healthcare NHS Foundation Trust), Dr David Hopkins (King's College London), Dr Peter Mansell (Nottingham University Hospitals NHS Trust), Dr Debbie Cooke (University of Surrey), Miss Carolin Taylor (Sheffield Teaching Hospitals NHS Foundation Trust), Professor Susan Michie (UCL), Mr Simon Fisher (Service user), Professor Stephanie Amiel (King's College London)
UCL team members	Dr Stephanie Stanton-Fay, Dr Fabiana Lorencatto, Dr Paul Chadwick
Project start and end dates	June 2016 -April 2023
Funder	NIHR Programme Grant for Applied Research
Project website	https://dafneplusresearch.wordpress.com/

Project Aims

The primary aim of this study is to conduct a cluster randomised controlled trial (RCT) comparing the new DAFNEplus intervention to the existing DAFNE programme

The primary objective is:
To assess the effects of the intervention on glycaemic control, as measured by HbA1c at 12 months.

The secondary objectives of this trial are:

To assess the effects of the intervention on the diabetes-specific quality of life.
To assess the medium term effect of the intervention on glycaemic control as measured by HbA1c using data at 6 months.
To assess the effects of the intervention on diabetes distress and other biomedical outcomes: (severe hypoglycaemic episodes, diabetic ketoacidosis, weight, body mass index, blood pressure and lipids).
To undertake a mixed methods process evaluation to aid understanding of the RCT findings, and to inform decision making about the implementation of DAFNEplus in clinical care post-trial.
To assess fidelity of delivery of the DAFNEplus intervention.
To undertake a health economic analysis to determine the cost-effectiveness of DAFNEplus versus standard DAFNE.

Project details

DAFNE (Dose Adjustment For Normal Eating) is a 5-day, group based training course for adults with Type 1 diabetes which has now been delivered to over 30,000 adults in the UK. The aim of DAFNEplus is to develop and convert DAFNE into a lifelong package to help people better manage their blood glucose levels long-term, as high levels can cause dangerous complications.

Our recent research confirmed that after attending a DAFNE course, people have better quality of life, better glucose levels (in the short-term) and are admitted to hospital less often for diabetes emergencies. Although participants find DAFNE training useful, some find it difficult to continually implement the skills needed to maintain glucose levels to prevent diabetic complications. After the course, people also find it difficult to get support from health professionals.

In phase 1 DAFNE graduates, educators, diabetes teams and psychologists will work together to review and re-develop the DAFNE course curriculum, using the Behavioural Change Wheel framework, such that it includes evidence-based behaviour change techniques that will promote skills in managing diabetes as part of peoples’ everyday lives. The support provided by health professionals following completion of the course will similarly be improved, the output of which will be a support package that enables DAFNEplus participants to sustain self-management behaviours and maintain improved glycaemic control. The revised curriculum and support package will additionally be assisted by the use of mobile, wireless and internet technology innovations.
In phase 2 the prototype course, and support package, will then be piloted, evaluated and modified in three centres running DAFNE courses over 12 months with up to 60 participants.

It is anticipated that a definitive pragmatic cluster RCT in 14 centres will then compare DAFNEplus (n=300) with standard DAFNE (n=300) over the course of 12 months on glucose levels, diabetes self-management behaviours, diabetes-specific self-efficacy, fear of hypoglycaemia/hypoglycaemia avoidance, diabetes-specific emotional distress and quality of life.

This work will help us develop better training for other groups (especially children and young people). The results may also be relevant to other long-term conditions, where people need to learn and apply complicated skills to manage their own condition as part of their everyday lives.