The Irish DAFNE study protocol: a cluster randomised trial of group versus individual follow-up after structured education for type 1 diabetes.
AuthorsDinneen, Seán F
O' Hara, Mary Clare
O' Shea, Donal
AffiliationDepartment of Medicine, Clinical Science Institute, National University of Ireland, Galway, Ireland. Sean.Dinneen@nuigalway.ie
Diabetes Mellitus, Type 1
Hemoglobin A, Glycosylated
Patient Education as Topic
MetadataShow full item record
CitationThe Irish DAFNE study protocol: a cluster randomised trial of group versus individual follow-up after structured education for type 1 diabetes. 2009, 10:88notTrials
AbstractBACKGROUND: Structured education programmes for individuals with Type 1 diabetes have become a recognised means of delivering the knowledge and skills necessary for optimal self-management of the condition. The Dose Adjustment for Normal Eating (DAFNE) programme has been shown to improve biomedical (HbA(1c) and rates of severe hypoglycaemia) and psychosocial outcomes for up to 12 months following course delivery. The optimal way to support DAFNE graduates and maintain the benefits of the programme has not been established. We aimed to compare 2 different methods of follow-up of DAFNE graduates in a pragmatic clinical trial delivered in busy diabetes clinics on the island of Ireland. METHODS: Six participating centres were cluster randomised to deliver either group follow-up or a return to traditional one-to-one clinic visits. In the intervention arm group follow-up was delivered at 6 and 12 months post DAFNE training according to a curriculum developed for the study. In the control arm patients were seen individually in diabetes clinics as part of routine care. Study outcomes included HbA(1c) levels, self-reported rates of severe hypoglycaemia, body weight and measures of diabetes wellbeing and quality of life. These were measured at 6, 12 and 18 months after recruitment. Generalisability (external validity) was maximised by recruiting study participants from existing DAFNE waiting lists in each centre, by using broad inclusion criteria (including HbA(1c) values less than 13 percent with no lower limit) and by using existing clinic staff to deliver the training and follow-up. Internal validity and treatment fidelity were maximised by quality assuring the training of all DAFNE educators, by external peer review of the group follow-up sessions and by striving for full attendance at follow-up visits. Assays of HbA(1c) were undertaken in a central laboratory. DISCUSSION: This pragmatic clinical trial evaluating group follow-up after a structured education programme has been designed to have broad generalisability. The results should inform how best to manage the well educated patient with Type 1 diabetes in the real world of clinical practice TRIAL REGISTRATION: Current Controlled Trials ISRCTN79759174.
- Structured, intensive education maximising engagement, motivation and long-term change for children and young people with diabetes: a cluster randomised controlled trial with integral process and economic evaluation - the CASCADE study.
- Authors: Christie D, Thompson R, Sawtell M, Allen E, Cairns J, Smith F, Jamieson E, Hargreaves K, Ingold A, Brooks L, Wiggins M, Oliver S, Jones R, Elbourne D, Santos A, Wong IC, O'Neill S, Strange V, Hindmarsh P, Annan F, Viner R
- Issue date: 2014 Mar
- Group follow-up compared to individual clinic visits after structured education for type 1 diabetes: a cluster randomised controlled trial.
- Authors: Dinneen SF, O'Hara MC, Byrne M, Smith D, Courtney CH, McGurk C, Heller SR, Newell J, Coffey N, Breen C, O'Scannail M, O'Shea D, Irish DAFNE Study Group.
- Issue date: 2013 Apr
- 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.
- Authors: Elliott J, Lawton J, Rankin D, Emery C, Campbell M, Dixon S, Heller S, NIHR DAFNE Research Study Group.
- Issue date: 2012 Nov 8
- Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial.
- Authors: DAFNE Study Group.
- Issue date: 2002 Oct 5
- The effect of the Talking Diabetes consulting skills intervention on glycaemic control and quality of life in children with type 1 diabetes: cluster randomised controlled trial (DEPICTED study).
- Authors: Robling M, McNamara R, Bennert K, Butler CC, Channon S, Cohen D, Crowne E, Hambly H, Hawthorne K, Hood K, Longo M, Lowes L, Pickles T, Playle R, Rollnick S, Thomas-Jones E, Gregory JW
- Issue date: 2012 Apr 26