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Open Access Highly Accessed Study protocol

Evidence into practice: evaluating a child-centred intervention for diabetes medicine management The EPIC Project

Jane P Noyes1*, Anne Williams2, Davina Allen2, Peter Brocklehurst3, Cynthia Carter4, John W Gregory5, Carol Jackson6, Mary Lewis7, Lesley Lowes2, Ian T Russell8, Joanne Rycroft-Malone1, Janice Sharp9, Mark Samuels10, Rhiannon Tudor Edwards11 and Rhiannon Whitaker12

Author Affiliations

1 Centre for Health-Related Research, Bangor University, Bangor UK

2 School of Nursing and Midwifery Studies, Cardiff University, Cardiff UK

3 National Perinatal Epidemiology Unit, University of Oxford, Oxford UK

4 Cardiff School of Journalism, Media and Cultural Studies, Cardiff University, Cardiff UK

5 Department of Child Health, Wales School of Medicine, Cardiff University, Cardiff UK

6 Pharmacy Department, Royal United Hospital Bath, Bath, UK

7 Centre for Adolescent and Child Health, University of Western England, Bristol UK

8 School of Medicine, Swansea University, Swansea UK

9 Media Resources Centre, University Hospital of Wales, Cardiff, UK

10 Formerly, Roche Diagnostics (UK) Ltd, now Head, Office for Clinical Research Infrastructure (NOCRI), London UK

11 Centre for Economics and Policy in Health, Bangor University, Bangor UK

12 North Wales Organisation for Randomised Trials in Health (NWORTH), Bangor University, Bangor UK

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BMC Pediatrics 2010, 10:70  doi:10.1186/1471-2431-10-70

Published: 27 September 2010

Abstract

Background

There is a lack of high quality, child-centred and effective health information to support development of self-care practices and expertise in children with acute and long-term conditions. In type 1 diabetes, clinical guidelines indicate that high-quality, child-centred information underpins achievement of optimal glycaemic control with the aim of minimising acute readmissions and reducing the risk of complications in later life. This paper describes the development of a range of child-centred diabetes information resources and outlines the study design and protocol for a randomized controlled trial to evaluate the information resources in routine practice. The aim of the diabetes information intervention is to improve children and young people's quality of life by increasing self-efficacy in managing their type 1 diabetes.

Methods/Design

We used published evidence, undertook qualitative research and consulted with children, young people and key stakeholders to design and produce a range of child-centred, age-appropriate children's diabetes diaries, carbohydrate recording sheets, and assembled child-centred, age-appropriate diabetes information packs containing published information in a folder that can be personalized by children and young people with pens and stickers. Resources have been designed for children/young people 6-10; 11-15; and 16-18 years.

To evaluate the information resources, we designed a pragmatic randomized controlled trial to assess the effectiveness, cost effectiveness, and implementation in routine practice of individually tailored, age-appropriate diabetes diaries and information packs for children and young people age 6-18years, compared with currently available standard practice.

Children and young people will be stratified by gender, length of time since diagnosis (< 2years and > 2years) and age (6-10; 11-15; and 16-18 years). The following data will be collected at baseline, 3 and 6 months: PedsQL (generic, diabetes and parent versions), and EQ-5 D (parent and child); NHS resource use and process data (questionnaire and interview). Baseline and subsequent HbA1c measurements, blood glucose meter use, readings and insulin dose will be taken from routine test results and hand-held records when attending routine 3-4 monthly clinic visits.

The primary outcome measure is diabetes self-efficacy and quality-of-life (Diabetes PedsQL). Secondary outcomes include: HbA1c, generic quality of life, routinely collected NHS/child-held data, costs, service use, acceptability and utility.

Trial Registration

ISRCTN17551624.