NCT02610738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2015

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

April 30, 2015

Last Update Submit

December 31, 2019

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (8)

  • Change in frequency of blood glucose testing

    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

    baseline and 3 months post course

  • Change in Knowledge assessment for key stage 2 children

    pre course , 2 weeks and 3 months post course

  • Change in HbA1c between baseline and 6 months

    Measured within 2 weeks pre course and at 3 and 6 months post course

  • change in blood glucose variability

    4 weeks pre course to 12 weeks post course

  • +3 more secondary outcomes

Study Arms (1)

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

Behavioral: Junior KICk-OFF education programme

Interventions

Junior KICk-OFF education programmeBEHAVIORAL

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

Also known as: Educational package
Junior KICk-OFF education programme

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child 4-11 years of age
  • Attending primary school
  • Type 1 diabetes\> 1 yr duration

You may not qualify if:

  • Non English speaking families
  • Significant learning difficulties
  • Co-morbidity likely to affect glycaemic control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kath Price

    Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

November 20, 2015

Study Start

January 1, 2015

Primary Completion

November 30, 2015

Study Completion

November 30, 2015

Last Updated

January 3, 2020

Record last verified: 2019-12

Locations

GB(1)