Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom
NCT Number: NCT02610738
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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Notify Me4 year–11 year
All sexes
Interventional
Not applicable
Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom
The aim of the study is to
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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
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
Time frame: baseline and 3 months post course
Validated questionnaires - Pediatric Quality of Life Inventory (PedsQL-G and D)
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.
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.
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
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
Time frame: baseline and 3 months
parent participants will complete validated questionnaire :PedsQL generic and PedsQL diabetes questionnaire
Time frame: baseline and 3 months
Completion of validated perceived stress questionnaire
Sheffield Children's NHS Foundation Trust
Other
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.
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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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