- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02610738
Junior KICkOFF: Diabetes Education for Children Under 11 Years
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sheffield (South Yorkshire District)
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Sheffield, Sheffield (South Yorkshire District), United Kingdom, S10 2TH
- Sheffield Children's NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative assessment of curriculum
Time Frame: post course- within 2 weeks
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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
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post course- within 2 weeks
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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
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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.
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during course delivery: three half days for keystage 1 children, three days for keystage 2 children
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Participant feedback on teaching
Time Frame: 3 days
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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
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3 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Blood glucose meters are downloaded using Diasend software at all clinic visits.
Analysis will record the total number of blood tests each week
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Change in number of tests for 4 weeks pre course and weekly for 3 months post course.
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Change in psychological outcomes: child participants in key stage two age group
Time Frame: baseline and 3 months post course
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Validated questionnaires - Pediatric Quality of Life Inventory (PedsQL-G and D)
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baseline and 3 months post course
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Change in Knowledge assessment for key stage 2 children
Time Frame: pre course , 2 weeks and 3 months post course
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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.
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pre course , 2 weeks and 3 months post course
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Change in HbA1c between baseline and 6 months
Time Frame: Measured within 2 weeks pre course and at 3 and 6 months post course
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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.
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Measured within 2 weeks pre course and at 3 and 6 months post course
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change in blood glucose variability
Time Frame: 4 weeks pre course to 12 weeks post course
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Blood glucose meter download on DIASEND will be analysed for day to day variability
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4 weeks pre course to 12 weeks post course
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change in weekly mean blood glucose level
Time Frame: from 4 weeks pre course to 12 weeks post course
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Data will be extracted from the Diasend software of all blood glocuse readings on the particpant blood glucose meter
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from 4 weeks pre course to 12 weeks post course
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Change in Quality of life - of child as assessed by parent participants
Time Frame: baseline and 3 months
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parent participants will complete validated questionnaire :PedsQL generic and PedsQL diabetes questionnaire
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baseline and 3 months
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Change in perceived stress - parent participants
Time Frame: baseline and 3 months
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Completion of validated perceived stress questionnaire
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baseline and 3 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kath Price, Investigator
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCH/14/036
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