Does an intensive self-management structured education course improve outcomes for children and young people with type 1 diabetes? The Kids In Control OF Food (KICk-OFF) cluster-randomised controlled trial protocol

Abstract

IntroductionThe Kids In Control OF Food (KICk-OFF) is a cluster-randomised controlled trial, which aims to determine the efficacy of a 5 day structured education course for 11-year-olds to 16-year-olds with type 1 diabetes (T1DM) when compared with standard care, and its cost effectiveness. Less than 15% of children and young people with T1DM in the UK meet the recommended glycaemic target. Self-management education programmes for adults with T1DM improve clinical and psychological outcomes, but none have been evaluated in the paediatric population. KICk-OFF is a 5-day structured education course for 11-year-olds to 16- year-olds with T1DM. It was developed with input from young people, parents, teachers and educationalists.Methods and analysis36 paediatric diabetes centres across the UK randomised into intervention and control arms. Up to 560 participants were recruited prior to centre randomisation. KICk-OFF courses are delivered in the intervention centres, with standard care continued in the control arm. Primary outcomes are change in glycaemic control (HbA1c) and quality of life between baseline and 6 months postintervention, and the incidence of severe hypoglycaemia. Sustained change in self-management behaviour is assessed by follow-up at 12 and 24 months. Health economic analysis will be undertaken. Data will be reported according to the CONSORT statement for cluster-randomised clinical trials. All analyses will be by intention-to-treat with a two-sided p value of <0.05 being regarded as statistically significant. The study commenced in 2008. Data collection from participants is ongoing and the study will be completed in 2013.EthicsThe study has been approved by the Sheffield Research Ethics Committee.DisseminationResults will be reported in peer reviewed journals and conferences.Trial registrationCurrent Controlled Trials ISRCTN37042683.

Effectiveness of the Kids in Control of Food (KICk–OFF) structured education course for 11–16 year olds with Type 1 diabetes

“…The protocol summarized below has been published previously [10]. Randomization was at cluster level and final analysis was by individual participant.…”

Cost-Effectiveness of Structured Education in Children With Type-1 Diabetes Mellitus

“…Centres were randomised to either KiCK-OFF(intervention) or usual care. Usual care is centre-specific education delivered without a clear structure [3]. This paper evaluates the cost-effectiveness of the KICk-OFF education programme compared to usual care.…”

“…The programme is based on the principles of the Dose Adjustment for Normal Eating (DAFNE) education programme for adults and aims to provide young people with self-management skills to help overcome some of the barriers to effective self-management associated with an intensive insulin regimen [3]. The key modules of the programme include: what is diabetes?…”

“…Type 1 diabetes usually appears before the age of 40, accounting for around 10 per cent of all people with diabetes [1]. In the UK, recent estimates of T1DM prevalence is one per 700 1,000 children [2], where less than 15% of them meet the recommended glycaemic target [3]. Self-management education programmes for adults with T1DM improve clinical outcomes and are cost-effective [4], [5].…”

“…The KICk-OFF trial was a cluster-randomised controlled trial which recruited 480 patients across 31 paediatric diabetes centres in the UK with a 2-year post-intervention follow-up period [3]. Centres were randomised to either KiCK-OFF(intervention) or usual care.…”