Type 1 DiabetesNCT02610738
Junior KICkOFF: Diabetes Education for Children Under 11 Years
A study testing Junior KICk-OFF education programme in people with Type 1 Diabetes, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Junior KICk-OFF education programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to 30 Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child 4-11 years of age
- Attending primary school
- Type 1 diabetes> 1 yr duration
Who cannot join
- Non English speaking families
- Significant learning difficulties
- Co-morbidity likely to affect glycaemic control
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH
About this study
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.
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Junior KICk-OFF education programme
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Junior KICk-OFF education programmeBehavioural
Also called Educational package
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
| Study group | Role | What they receive |
|---|---|---|
| Junior KICk-OFF education programme | Experimental | Participants will attend an age appropriate self management programme (Junior KICk-OFF) designed to improve their knowledge and understanding of type 1 diabetes Receives: Behavioral: Junior KICk-OFF education programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: post course- within 2 weeks
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.
Measured: during course delivery: three half days for keystage 1 children, three days for keystage 2 children
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
Measured: 3 days
Secondary outcomes (8)
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
Measured: Change in number of tests for 4 weeks pre course and weekly for 3 months post course.
Change in psychological outcomes: child participants in key stage two age group
Validated questionnaires - Pediatric Quality of Life Inventory (PedsQL-G and D)
Measured: baseline and 3 months post course
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.
Measured: pre course , 2 weeks and 3 months post course
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: Measured within 2 weeks pre course and at 3 and 6 months post course
change in blood glucose variability
Blood glucose meter download on DIASEND will be analysed for day to day variability
Measured: 4 weeks pre course to 12 weeks post course
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
Measured: from 4 weeks pre course to 12 weeks post course
Change in Quality of life - of child as assessed by parent participants
parent participants will complete validated questionnaire :PedsQL generic and PedsQL diabetes questionnaire
Measured: baseline and 3 months
Change in perceived stress - parent participants
Completion of validated perceived stress questionnaire
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJan 2015
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, University of Leeds, University Hospitals of Derby and Burton NHS Foundation Trust, Sheffield Hallam University
- Responsible party
- Sponsor
- Investigators
- Kath Price, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610738
- Sponsor's protocol ID
- SCH/14/036
- Status last verified
- Dec 2019
- First submitted
- 30 Apr 2015
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02610738
- Acronym / sponsor ID
- SCH/14/036
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield, University of Leeds, University Hospitals of Derby and Burton NHS Foundation Trust, Sheffield Hallam University
- Study start
- Jan 2015
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Junior KICk-OFF education programme | Experimental | Behavioral: Junior KICk-OFF education programmeParticipants will attend an age appropriate self management programme (Junior KICk-OFF) designed to improve their knowledge and understanding of type 1 diabetes |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child 4-11 years of age
- Attending primary school
- Type 1 diabetes> 1 yr duration
Key exclusion criteria (3 listed)
- Non English speaking families
- Significant learning difficulties
- Co-morbidity likely to affect glycaemic control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Junior KICk-OFF education programmeAlso: Educational packageThe 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 | Behavioural | Junior KICk-OFF education programme |
Primary outcome
Qualitative assessment of curriculum
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
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
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
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
8 secondary outcomes
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.
Change in psychological outcomes: child participants in key stage two age group
Time frame: baseline and 3 months post course
Change in Knowledge assessment for key stage 2 children
Time frame: pre course , 2 weeks and 3 months post course
Change in HbA1c between baseline and 6 months
Time frame: Measured within 2 weeks pre course and at 3 and 6 months post course
change in blood glucose variability
Time frame: 4 weeks pre course to 12 weeks post course
change in weekly mean blood glucose level
Time frame: from 4 weeks pre course to 12 weeks post course
Change in Quality of life - of child as assessed by parent participants
Time frame: baseline and 3 months
Change in perceived stress - parent participants
Time frame: baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kath Price principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Junior KICk-OFF education programme in people with Type 1 Diabetes, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative assessment of curriculum (time frame: post course- within 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.