Junior KICkOFF: Diabetes Education for Children Under 11 Years

Type 1 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610738
• Other study ID #: SCH/14/036
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: November 30, 2015

Study information

• Verified date: December 2019
• Source: Sheffield Children's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: November 30, 2015
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United Kingdom	Sheffield Children's NHS Foundation Trust	Sheffield	Sheffield (South Yorkshire District)

Sponsors (5)

Lead Sponsor	Collaborator
Sheffield Children's NHS Foundation Trust	Sheffield Hallam University, University Hospitals of Derby and Burton NHS Foundation Trust, University of Leeds, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative assessment of curriculum	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	post course- within 2 weeks
Primary	Educational evaluation through observation of junior KICk-OFF courses	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.	during course delivery: three half days for keystage 1 children, three days for keystage 2 children
Primary	Participant feedback on teaching	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	3 days
Secondary	Change in frequency of blood glucose testing	Blood glucose meters are downloaded using Diasend software at all clinic visits. Analysis will record the total number of blood tests each week	Change in number of tests for 4 weeks pre course and weekly for 3 months post course.
Secondary	Change in psychological outcomes: child participants in key stage two age group	Validated questionnaires - Pediatric Quality of Life Inventory (PedsQL-G and D)	baseline and 3 months post course
Secondary	Change in Knowledge assessment for key stage 2 children	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.	pre course , 2 weeks and 3 months post course
Secondary	Change in HbA1c between baseline and 6 months	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.	Measured within 2 weeks pre course and at 3 and 6 months post course
Secondary	change in blood glucose variability	Blood glucose meter download on DIASEND will be analysed for day to day variability	4 weeks pre course to 12 weeks post course
Secondary	change in weekly mean blood glucose level	Data will be extracted from the Diasend software of all blood glocuse readings on the particpant blood glucose meter	from 4 weeks pre course to 12 weeks post course
Secondary	Change in Quality of life - of child as assessed by parent participants	parent participants will complete validated questionnaire :PedsQL generic and PedsQL diabetes questionnaire	baseline and 3 months
Secondary	Change in perceived stress - parent participants	Completion of validated perceived stress questionnaire	baseline and 3 months