Evidence into Practice: evaluating a Child-centred intervention for diabetes medicine management

ISRCTN	ISRCTN17551624
DOI	https://doi.org/10.1186/ISRCTN17551624
Protocol serial number	0001653
Sponsor	Cardiff University (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Service Delivery and Organisation (SDO) Programme (ref: 0001653)

Submission date: 12/06/2008
Registration date: 23/06/2008
Last edited: 03/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Anne Williams
Scientific

Nursing, Health and Social Care Research Centre
School of Nursing & Midwifery Studies
Eastgate House
35-43 Newport Road
Cardiff
CF24 0AB
United Kingdom

Phone	+44 (0)29 2091 7816
Email	awglanrhyd@aol.com

Study information

Primary study design	Interventional
Study design	Pragmatic randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evidence into Practice: evaluating a Child-centred intervention for diabetes medicine management
Study acronym	EPIC
Study objectives	Little evidence exists concerning the effectiveness of the types and formats of information that could empower children to make decisions regarding medicines and self-care. For children with type one diabetes, intensive structured education programmes exist, however there is insufficient evidence about the effectiveness of information underpinning these programmes or routine clinical management. Aim: To develop and evaluate an individually-tailored, age-appropriate information resource to support decision-making and self-care relating to insulin management and electronic blood glucose monitoring for children aged 6 - 18 years with type one diabetes, compared with available resources (if any) in routine clinical practice. Objectives: 1. Review gold-standard clinical guidelines, currently available information including findings from completed Phase 1 of current SDO/145/2007 to identify best practice, and types/formats of information most likely to assist age-appropriate decision-making and choices concerning blood glucose monitoring and insulin management 2. Develop an age-appropriate child-centred information resource for children/young people, to support appropriate use of blood glucose meters to optimise management of and concordance with their insulin regime 3. Explore the utility of the resource within different contexts in which children manage their routine diabetes care (home, school, community) with and without support from parents or healthcare professionals, and in alternative settings 4. Explore how children with and without their parents, teachers, nurses, doctors use (or not) the information resource to support decision-making; in particular how children/parents 'self-prescribe' the correct (or incorrect) dose of insulin 5. Identify similarities and differences between the resource developed for adolescents and those available within adult diabetes services 6. Evaluate the resource within the context of routine diabetes care in relation to patient outcomes (diabetes-specific, health-related quality-of-life concordance, acceptability, ease of use, and glycaemic control) 7. Identify gaps in knowledge
Ethics approval(s)	Ethics approval pending as of 12/06/2008.
Health condition(s) or problem(s) studied	Type one diabetes
Intervention	The investigation is a mixed-method study informed by the 'Promoting Action on Research Implementation in Health Services' (PARIHS) framework which has been widely used to inform design and evaluation of evidence-into-practice initiatives. To meet our objectives which are aligned with the phases of the Medical Research Council (MRC) framework for randomised controlled trials (RCTs) of complex interventions we have designed a four-stage study: Stage 1: Review and, where appropriate, undertake further work to identify types/formats of information most likely to assist age-appropriate decision-making/choices related to children/young people with type one diabetes. Duration: April 2008 to October 2008. Stage 2: Construct an exemplar information resource, piloting for variations as necessary. Duration: November 2008 to October 2009. Stage 3: Conduct a pragamatic evaluation to assess utility, acceptability effectiveness and cost effectiveness of the information resource. Duration: November 2009 to June 2010. Stage 4: Undertake data synthesis and comparative analysis. Duration: July 2009 to March 2011. The intervention lasts for 8 months with a follow-up at 3 months from baseline and 3 months from first follow-up.
Intervention type	Other
Primary outcome measure(s)	Choice of outcomes is guided by Health Technology Assessment (HTA) commissioned systematic reviews recommending that HbA1c (glycaemic control measure) is not the appropriate primary outcome on which to assess benefits of an intervention designed to more directly effect behaviour/self-management. Therefore, the primary outcome measure is diabetes self-efficacy and quality-of-life using the Diabetes Pediatric Quality of Life Inventory (PedsQol). Outcomes will be measured at baseline, 3 months (follow-up 1) and 6 months (follow-up 2).
Key secondary outcome measure(s)	1. HbA1c 2. Generic quality of life 3. Routinely collected NHS/child-held data costs 4. Service use 5. Acceptability/utility Outcomes will be measured at baseline, 3 months (follow-up 1) and 6 months (follow-up 2).
Completion date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. Children aged 6 - 18 years, either sex 2. Type one diabetes
Key exclusion criteria	1. Severe learning difficulties 2. Significant social problems 3. Needle phobias
Date of first enrolment	01/02/2009
Date of final enrolment	01/09/2010

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Nursing, Health and Social Care Research Centre

Cardiff
CF24 0AB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2014		Yes	No
Protocol article	protocol	27/09/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes