Clinical trial NCT02610738: Junior KICkOFF: Diabetes Education for Children Under 11 Years
Official title: Junior KICk-OFF. Development and Pilot Evaluation of Structured Self-management Education Packages for Children 11 Years of Age and Under With Type 1 Diabetes, Their Parents and Carers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
name: University of Leeds
name: University Hospitals of Derby and Burton NHS Foundation Trust
name: Sheffield Hallam University
First posted: 2015-11-20
Enrollment: 2
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to develop educational packages for children of primary school age with type 1 diabetes and their parents, and to undertake a small scale feasibility study to allow evaluation of the curriculum. Paediatric diabetes teams in the United Kingdom currently deliver education using largely unevaluated teaching materials. By working with the education profession the investigators aim to develop packages which are based on recognised educational theory and practice. The investigators hope that use of these will result in better blood glucose control, reducing the risk of longterm diabetes complications such as eye and kidney disease.

Detailed description: The aim of the study is to

1. To produce an educational curriculum and teaching material for three groups

   * Key stage one (KS1)(4-7 yrs)
   * Key stage two (KS2) (8-11 yrs)
   * Parents
2. To undertake pilot evaluation to establish

   * the feasibility of running the different education sessions, addressing access and other practical issues
   * the educational value of the packages produced with the aim of further refinement of the curriculum
   * the acceptability of the sessions to participants and parents
   * a process evaluation of the individual components of the packages
   * potential biomedical and psychological benefits, to provide data for a power calculation for a larger randomised controlled trial of the effectiveness of the educational package

The first phase of the project involves development of curriculum for the education of 4-11 yr old children with type 1 diabetes. Participants in key stage one will be taught a basic understanding of carbohydrate, exercise and insulin balance, hypoglycaemia and injections/pump basics and blood glucose testing. Older participants (Key stage two) will be taught similar topics but with increasing complexity appropriate to their age and understanding. The teaching will use approaches similar to those employed in schools and therefore the research team will work with primary school teachers and experts in education to ensure appropriate techniques and resources are employed. The focus of the education for parents will be to help them teach and encourage their children to develop their diabetes skills as they grow up.

The second phase of the project involves delivery of courses to each age group. The main focus of this will be to assess the acceptability of the curriculum. Feasibility in terms of practical arrangements, timing, use of resources etc will be examined. Feedback from an independent expert observer as well as from participants and educators will allow the curriculum to be assessed and adapted if necessary prior to larger scale study.

Some outcome measures are being examined. The investigators aim to assess whether older children's knowledge has changed pre and post course, whether diabetes self management within the family has altered and whether there is any impact on glycaemic control and quality of life.

Eligibility criteria: Inclusion Criteria:

* Child 4-11 years of age
* Attending primary school
* Type 1 diabetes\> 1 yr duration

Exclusion Criteria:

* Non English speaking families
* Significant learning difficulties
* Co-morbidity likely to affect glycaemic control

Primary outcomes:
measure: Qualitative assessment of curriculum
timeFrame: post course- within 2 weeks
measure: Educational evaluation through observation of junior KICk-OFF courses
timeFrame: during course delivery: three half days for keystage 1 children, three days for keystage 2 children
measure: Participant feedback on teaching
timeFrame: 3 days
Secondary outcomes:
measure: Change in frequency of blood glucose testing
timeFrame: Change in number of tests for 4 weeks pre course and weekly for 3 months post course.
measure: Change in psychological outcomes: child participants in key stage two age group
timeFrame: baseline and 3 months post course
measure: Change in Knowledge assessment for key stage 2 children
timeFrame: pre course , 2 weeks and 3 months post course
measure: Change in HbA1c between baseline and 6 months
timeFrame: Measured within 2 weeks pre course and at 3 and 6 months post course
measure: change in blood glucose variability
timeFrame: 4 weeks pre course to 12 weeks post course
measure: change in weekly mean blood glucose level
timeFrame: from 4 weeks pre course to 12 weeks post course
measure: Change in Quality of life - of child as assessed by parent participants
timeFrame: baseline and 3 months
measure: Change in perceived stress - parent participants
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
state: Sheffield (South Yorkshire District)
Study officials:
affiliation: Investigator
name: Kath Price
role: PRINCIPAL_INVESTIGATOR
References: