title: Evidence into practice: evaluating a child-centred intervention for diabetes medicine management. The EPIC Project.
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
  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 6-18 years, compared with currently available standard practice.Children and young people will be stratified by gender, length of time since diagnosis (< 2 years and > 2 years) 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.
  
  
  BACKGROUND
  ISRCTN17551624.
authors.affiliation: Centre for Health-Related Research, Bangor University, Bangor, UK. jane.noyes@bangor.ac.uk
authors.forename: Jane P
authors.initials: JP
authors.lastname: Noyes
authors.forename: Anne
authors.initials: A
authors.lastname: Williams
authors.forename: Davina
authors.initials: D
authors.lastname: Allen
authors.forename: Peter
authors.initials: P
authors.lastname: Brocklehurst
authors.forename: Cynthia
authors.initials: C
authors.lastname: Carter
authors.forename: John W
authors.initials: JW
authors.lastname: Gregory
authors.forename: Carol
authors.initials: C
authors.lastname: Jackson
authors.forename: Mary
authors.initials: M
authors.lastname: Lewis
authors.forename: Lesley
authors.initials: L
authors.lastname: Lowes
authors.forename: Ian T
authors.initials: IT
authors.lastname: Russell
authors.forename: Joanne
authors.initials: J
authors.lastname: Rycroft-Malone
authors.forename: Janice
authors.initials: J
authors.lastname: Sharp
authors.forename: Mark
authors.initials: M
authors.lastname: Samuels
authors.forename: Rhiannon Tudor
authors.initials: RT
authors.lastname: Edwards
authors.forename: Rhiannon
authors.initials: R
authors.lastname: Whitaker
mesh_terms: D000293:Adolescent; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000379:methods*; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000628:therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000627:therapeutic use*; D008297:Male; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D012648:Self Care / Q000592:standards*; D011795:Surveys and Questionnaires
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin