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Junior KICkOFF: Diabetes Education for Children Under 11 Years

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Junior KICk-OFF education programme
Sponsored by
Sheffield Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes

Eligibility Criteria

4 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheffield Children's NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Junior KICk-OFF education programme

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.
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

Secondary Outcome Measures

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 psychological outcomes: child participants in key stage two age group
Validated questionnaires - Pediatric Quality of Life Inventory (PedsQL-G and D)
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.
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.
change in blood glucose variability
Blood glucose meter download on DIASEND will be analysed for day to day variability
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
Change in Quality of life - of child as assessed by parent participants
parent participants will complete validated questionnaire :PedsQL generic and PedsQL diabetes questionnaire
Change in perceived stress - parent participants
Completion of validated perceived stress questionnaire

Full Information

First Posted
April 30, 2015
Last Updated
December 31, 2019
Sponsor
Sheffield Children's NHS Foundation Trust
Collaborators
University of Sheffield, University of Leeds, University Hospitals of Derby and Burton NHS Foundation Trust, Sheffield Hallam University
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1. Study Identification

Unique Protocol Identification Number
NCT02610738
Brief Title
Junior KICkOFF: Diabetes Education for Children Under 11 Years
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 30, 2015 (Actual)
Study Completion Date
November 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust
Collaborators
University of Sheffield, University of Leeds, University Hospitals of Derby and Burton NHS Foundation Trust, Sheffield Hallam University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Junior KICk-OFF education programme
Arm Type
Experimental
Arm Description
Participants will attend an age appropriate self management programme (Junior KICk-OFF) designed to improve their knowledge and understanding of type 1 diabetes
Intervention Type
Behavioral
Intervention Name(s)
Junior KICk-OFF education programme
Other Intervention Name(s)
Educational package
Intervention Description
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
Primary Outcome Measure Information:
Title
Qualitative assessment of curriculum
Description
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
post course- within 2 weeks
Title
Educational evaluation through observation of junior KICk-OFF courses
Description
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
during course delivery: three half days for keystage 1 children, three days for keystage 2 children
Title
Participant feedback on teaching
Description
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
3 days
Secondary Outcome Measure Information:
Title
Change in frequency of blood glucose testing
Description
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
Change in number of tests for 4 weeks pre course and weekly for 3 months post course.
Title
Change in psychological outcomes: child participants in key stage two age group
Description
Validated questionnaires - Pediatric Quality of Life Inventory (PedsQL-G and D)
Time Frame
baseline and 3 months post course
Title
Change in Knowledge assessment for key stage 2 children
Description
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
pre course , 2 weeks and 3 months post course
Title
Change in HbA1c between baseline and 6 months
Description
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
Measured within 2 weeks pre course and at 3 and 6 months post course
Title
change in blood glucose variability
Description
Blood glucose meter download on DIASEND will be analysed for day to day variability
Time Frame
4 weeks pre course to 12 weeks post course
Title
change in weekly mean blood glucose level
Description
Data will be extracted from the Diasend software of all blood glocuse readings on the particpant blood glucose meter
Time Frame
from 4 weeks pre course to 12 weeks post course
Title
Change in Quality of life - of child as assessed by parent participants
Description
parent participants will complete validated questionnaire :PedsQL generic and PedsQL diabetes questionnaire
Time Frame
baseline and 3 months
Title
Change in perceived stress - parent participants
Description
Completion of validated perceived stress questionnaire
Time Frame
baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kath Price
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Children's NHS Foundation Trust
City
Sheffield
State/Province
Sheffield (South Yorkshire District)
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

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Junior KICkOFF: Diabetes Education for Children Under 11 Years

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