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Open Access Study protocol

The 5x1 DAFNE study protocol: a cluster randomised trial comparing a standard 5 day DAFNE course delivered over 1 week against DAFNE training delivered over 1 day a week for 5 consecutive weeks

Jackie Elliott1*, Julia Lawton2, David Rankin2, Celia Emery3, Mike Campbell4, Simon Dixon4, Simon Heller1 and on behalf of the NIHR DAFNE Research Study Group

Author Affiliations

1 Academic Unit of Diabetes, Endocrinology & Metabolism, Department of Human Metabolism, The University of Sheffield, The Medical School, Beech Hill Road, Sheffield, S10 2RX, UK

2 Centre for Population Health Sciences, The University of Edinburgh, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK

3 DAFNE NIHR Project Office, 11 Broomfield Rd, Sheffield, S10 2SE, UK

4 School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK

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BMC Endocrine Disorders 2012, 12:28  doi:10.1186/1472-6823-12-28

Published: 8 November 2012

Abstract

Background

Structured education programmes are now established as an essential component to assist effective self-management of diabetes. In the case of Type 1 diabetes, the Dose Adjustment For Normal Eating (DAFNE) programme improves both glycaemic control and quality of life. Traditionally delivered over five consecutive days, this format has been cited as a barrier to participation by some patients, such as those who work full-time. Some centres in the UK have organised structured education programmes to be delivered one day a week over several consecutive weeks. This type of format may add benefit by allowing more time in which to practice skills between sessions, but may suffer as a result of weaker peer support being generated compared to that formed over five consecutive days.

Methods/design

We aim to compare DAFNE delivered over five consecutive days (1 week course) with DAFNE delivered one day a week over five weeks (5 week course) in a randomised controlled trial. A total of 213 patients were randomised to attend either a 1 week or a 5 week course delivered in seven participating centres. Study outcomes (measured at baseline, 6 and 12 months post-course) include HbA1c, weight, self-reported rates of severe hypoglycaemia, psychosocial measures of quality of life, and cost-effectiveness. Generalisability was optimised by recruiting patients from DAFNE waiting lists at each centre, and by mailing eligible patients from hospital clinic lists. The inclusion and exclusion criteria were identical to those used to recruit to a standard DAFNE course (e.g., HbA1c <12%, with no lower limit). Qualitative interviews were undertaken with a sub-sample of n=30 patients and their course educators (n=11) to help understand and interpret differences and similarities in outcomes between the two arms, and to identify logistical problems and unanticipated issues arising from the adaptation and delivery of a 5 week course.

Discussion

This trial has been designed to test the hypothesis that the benefits of delivering a structured education programme over 5 weeks are comparable to those observed after a 1 week course. The results of the trial and the qualitative sub-study will both inform the design and delivery of future DAFNE courses, and the development of structured education programmes in other fields of medicine.

Trial Registration

Clinicaltrials.gov NCT01069393

Keywords:
Type 1 diabetes; Education; Teaching; Training programs