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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Qualitative assessment of curriculum
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child 4-11 years of age
- •Attending primary school
- •Type 1 diabetes> 1 yr duration
排除标准
- •Non English speaking families
- •Significant learning difficulties
- •Co-morbidity likely to affect glycaemic control
研究组 & 干预措施
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
干预措施: Junior KICk-OFF education programme (Behavioral)
结局指标
主要结局
Qualitative assessment of curriculum
时间窗: 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
Participant feedback on teaching
时间窗: 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
Educational evaluation through observation of junior KICk-OFF courses
时间窗: 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.
次要结局
- Change in psychological outcomes: child participants in key stage two age group(baseline 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 weekly mean blood glucose level(from 4 weeks pre course to 12 weeks post course)
- Change in perceived stress - parent participants(baseline and 3 months)
- change in blood glucose variability(4 weeks pre course to 12 weeks post course)
- Change in Quality of life - of child as assessed by parent participants(baseline and 3 months)
- 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 Knowledge assessment for key stage 2 children(pre course , 2 weeks and 3 months post course)