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Completed

NCT Number: NCT02610738

Junior KICkOFF: Diabetes Education for Children Under 11 Years

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.

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Key information

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom

About this study

The aim of the study is to

  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Junior KICk-OFF education programme

Behavioral

The Junior KICk-OFF course is an age appropriate eduction course which aims to improve the understanding and knowledge of children with type 1 diabetes. It has been designed with school teachers and educationalists to meet the learning needs of children aged 4-11yrs

Other names: Educational package

Primary outcomes

  1. Qualitative assessment of curriculum

    Time frame: post course- within 2 weeks

    Interviews with participants (parents and children) using semistructured interview schedule. Investigators will be seeking opinion about the usefulness of the course, whether any sections failed to meet their needs and whether they felt their self management behaviour around diabetes has been influenced

  2. Educational evaluation through observation of junior KICk-OFF courses

    Time frame: during course delivery: three half days for keystage 1 children, three days for keystage 2 children

    An independent academic educationalist will observe course delivery and using a structured assessment sheet will assess fidelity with the curriculum, engagement of learners, assessment of learning needs and delivery of the curriculum.

  3. Participant feedback on teaching

    Time frame: 3 days

    Written and verbal evaluation will be sought at end of each day of the course to assess immediate acceptability of the curriculum and identification of elements which are successful or otherwise

Secondary outcomes

  1. Change in frequency of blood glucose testing

    Time frame: Change in number of tests for 4 weeks pre course and weekly for 3 months post course.

    Blood glucose meters are downloaded using Diasend software at all clinic visits. Analysis will record the total number of blood tests each week

  2. Change in psychological outcomes: child participants in key stage two age group

    Time frame: baseline and 3 months post course

    Validated questionnaires - Pediatric Quality of Life Inventory (PedsQL-G and D)

  3. Change in Knowledge assessment for key stage 2 children

    Time frame: pre course , 2 weeks and 3 months post course

    A quiz and practical assessment of knowledge has been developed for participants aged 8-10 yrs. By posing scenarios investigators will assess their knowledge and understanding of diabetes.

  4. Change in HbA1c between baseline and 6 months

    Time frame: Measured within 2 weeks pre course and at 3 and 6 months post course

    HbA1c is a measure of glycaemic control which is recorded routinely in diabetes care. A sample will be collected in clinic or at baseline data collection.

  5. change in blood glucose variability

    Time frame: 4 weeks pre course to 12 weeks post course

    Blood glucose meter download on DIASEND will be analysed for day to day variability

  6. change in weekly mean blood glucose level

    Time frame: from 4 weeks pre course to 12 weeks post course

    Data will be extracted from the Diasend software of all blood glocuse readings on the particpant blood glucose meter

  7. Change in Quality of life - of child as assessed by parent participants

    Time frame: baseline and 3 months

    parent participants will complete validated questionnaire :PedsQL generic and PedsQL diabetes questionnaire

  8. Change in perceived stress - parent participants

    Time frame: baseline and 3 months

    Completion of validated perceived stress questionnaire

Sponsors and collaborators

Lead sponsor

Sheffield Children's NHS Foundation Trust

Other

Collaborators

  • Sheffield Hallam University
  • University Hospitals of Derby and Burton NHS Foundation Trust
  • University of Leeds
  • University of Sheffield

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2015
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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