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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

Coates, E, Amiel, S, Baird, W, Benaissa, M, Brennan, A, Campbell, MJ, Chadwick, P, Chater, T, Choudhary, P, Cooke, D, Cooper, C, Cross, E, De Zoysa, N, Eissa, M, Elliott, J, Gianfrancesco, C, Good, T, Hopkins, D, Hui, Z, Lawton, J, Lorencatto, F, Michie, S, Pollard, DJ, Rankin, D, Schutter, J, Scott, E, Speight, Jane, Stanton-Fay, S, Taylor, C, Thompson, G, Totton, N, Yardley, L, Zaitcev, A and Heller, S 2021, 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, BMJ open, vol. 11, no. 1, pp. 1-11, doi: 10.1136/bmjopen-2020-040438.

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Title 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
Author(s) Coates, E
Amiel, S
Baird, W
Benaissa, M
Brennan, A
Campbell, MJ
Chadwick, P
Chater, T
Choudhary, P
Cooke, D
Cooper, C
Cross, E
De Zoysa, N
Eissa, M
Elliott, J
Gianfrancesco, C
Good, T
Hopkins, D
Hui, Z
Lawton, J
Lorencatto, F
Michie, S
Pollard, DJ
Rankin, D
Schutter, J
Scott, E
Speight, JaneORCID iD for Speight, Jane orcid.org/0000-0002-1204-6896
Stanton-Fay, S
Taylor, C
Thompson, G
Totton, N
Yardley, L
Zaitcev, A
Heller, S
Journal name BMJ open
Volume number 11
Issue number 1
Article ID e040438
Start page 1
End page 11
Total pages 11
Publisher BMJ
Place of publication London, Eng.
Publication date 2021-01-18
ISSN 2044-6055
2044-6055
Keyword(s) diabetes & endocrinology
education & training (see medical education & training)
health economics
qualitative research
DAFNEplus group
Summary IntroductionThe 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 analysisA 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 disseminationEthics 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 numberISRCTN42908016.
Language eng
DOI 10.1136/bmjopen-2020-040438
Field of Research 1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
HERDC Research category C1 Refereed article in a scholarly journal
Free to Read? Yes
Persistent URL http://hdl.handle.net/10536/DRO/DU:30148164

Document type: Journal Article
Collections: Faculty of Health
School of Psychology
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.