Junior KICkOFF: Diabetes Education for Children Under 11 Years

NCT ID: NCT02610738

Last Updated: 2020-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-11-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Junior KICk-OFF education programme

Participants will attend an age appropriate self management programme (Junior KICk-OFF) designed to improve their knowledge and understanding of type 1 diabetes

Group Type: EXPERIMENTAL

Junior KICk-OFF education programme

Intervention Type: 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

Interventions

Junior KICk-OFF education programme

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Educational package

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sheffield

OTHER

Sponsor Role: collaborator

University of Leeds

OTHER

Sponsor Role: collaborator

University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Sheffield Hallam University

OTHER

Sponsor Role: collaborator

Sheffield Children's NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kath Price

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), United Kingdom

Countries

United Kingdom

Other Identifiers

SCH/14/036

Identifier Type: -

Identifier Source: org_study_id