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

ISRCTN ISRCTN17551624
DOI https://doi.org/10.1186/ISRCTN17551624
Secondary identifying numbers 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

Study designPragmatic randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvidence into Practice: evaluating a Child-centred intervention for diabetes medicine management
Study acronymEPIC
Study objectivesLittle 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) studiedType one diabetes
InterventionThe 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 typeOther
Primary outcome measureChoice 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 measures1. 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 study start date01/02/2009
Completion date01/09/2010

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Years
Upper age limit18 Years
SexBoth
Target number of participants200
Key inclusion criteria1. Children aged 6 - 18 years, either sex
2. Type one diabetes
Key exclusion criteria1. Severe learning difficulties
2. Significant social problems
3. Needle phobias
Date of first enrolment01/02/2009
Date of final enrolment01/09/2010

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

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

Sponsor information

Cardiff University (UK)
University/education

7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom

Phone +44 (0)29 2087 5834
Email davieskp2@cf.ac.uk
Website http://www.cardiff.ac.uk/
ROR logo "ROR" https://ror.org/03kk7td41

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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