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
| Autor: | Elizabeth Coates, Jose Schutter, Elizabeth J. Cross, Nicole de Zoysa, Carla Gianfrancesco, Lucy Yardley, Alan Brennan, Julia Lawton, Stephanie H Stanton-Fay, Debbie Cooke, Jane Speight, Paul Chadwick, Simon Heller, Zheng Hui, Tim Chater, David Hopkins, Wendy Baird, Mohammad R. Eissa, Tim Good, Nikki Totton, Fabiana Lorencatto, Cindy Cooper, Stephanie A. Amiel, David W. H. Rankin, Mohammed Benaissa, Carolin Taylor, Michael J. Campbell, Elaine Scott, Daniel Pollard, Aleksandr Zaitcev, Jackie Elliott, Susan Michie, G. Thompson, Pratik Choudhary |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
medicine.medical_specialty diabetes & endocrinology 030209 endocrinology & metabolism patient education State Medicine law.invention 03 medical and health sciences 0302 clinical medicine Quality of life (healthcare) Randomized controlled trial Patient Education as Topic law Clinical endpoint Medicine health economics Humans 030212 general & internal medicine Cluster randomised controlled trial Randomized Controlled Trials as Topic Glycated Hemoglobin Type 1 diabetes Self-management business.industry Self-Management General Medicine medicine.disease education & training (see medical education & training) Diabetes and Endocrinology diabetes mellitus type 1 self management Diabetes Mellitus Type 1 Physical therapy Quality of Life DAFNE Physical and Mental Health business randomised controlled trial qualitative research Patient education |
| Zdroj: | BMJ Open Coates, E, Amiel, S, Baird, W, Benaissa, M, Brennan, A, Campbell, M J, 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 F, Pollard, D J, Rankin, D, Schutter, J, Scott, E, Speight, J, Stanton-Fay, S, Taylor, C, Thompson, G, Totton, N, Yardley, L, Zaitcev, A & 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, e040438, pp. e040438 . https://doi.org/10.1136/bmjopen-2020-040438 Coates, E, Amiel, S, Baird, W, Lawton, J & Rankin, D 2021, ' A 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. e040438 . https://doi.org/10.1136/bmjopen-2020-040438 |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2020-040438 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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