Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/06/2008
Date assigned
23/06/2008
Last edited
03/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anne Williams

ORCID ID

Contact details

Nursing
Health and Social Care Research Centre
School of Nursing & Midwifery Studies
Eastgate House
35-43 Newport Road
Cardiff
CF24 0AB
United Kingdom
+44 (0)29 2091 7816
awglanrhyd@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0001653

Study information

Scientific title

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

Acronym

EPIC

Study hypothesis

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

Ethics approval pending as of 12/06/2008.

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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).

Secondary outcome measures

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).

Overall trial start date

01/02/2009

Overall trial end date

01/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 6 - 18 years, either sex
2. Type one diabetes

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Severe learning difficulties
2. Significant social problems
3. Needle phobias

Recruitment start date

01/02/2009

Recruitment end date

01/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nursing, Health and Social Care Research Centre
Cardiff
CF24 0AB
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom
+44 (0)29 2087 5834
davieskp2@cf.ac.uk

Sponsor type

University/education

Website

http://www.cardiff.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Service Delivery and Organisation (SDO) Programme (ref: 0001653)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20875112
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25642573

Publication citations

  1. Protocol

    Noyes JP, Williams A, Allen D, Brocklehurst P, Carter C, Gregory JW, Jackson C, Lewis M, Lowes L, Russell IT, Rycroft-Malone J, Sharp J, Samuels M, Edwards RT, Whitaker R, Evidence into practice: evaluating a child-centred intervention for diabetes medicine management. The EPIC Project., BMC Pediatr, 2010, 10, 70, doi: 10.1186/1471-2431-10-70.

  2. Results

    Noyes JP, Lowes L, Whitaker R, Allen D, Carter C, Edwards RT, Rycroft-Malone J, Sharp J, Edwards D, Spencer LH, Sylvestre Y, Yeo ST, Gregory JW, Developing and evaluating a child-centred intervention for diabetes medicine management using mixed methods and a multicentre randomised controlled trial.

Additional files

Editorial Notes