Maximising engagement, motivation and long-term change in a structured intensive education programme in diabetes for children, young people and their families: Child and Adolescent Structured Competencies Approach to Diabetes Educatio

Not Applicable

Completed

• Conditions: Diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN52537669
• Lead Sponsor: niversity College London Hospital (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-08
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

Current inclusion criteria as of 16/10/2012:
1. Subjects 8 - 16 years with type 1 diabetes
2. HbA1c greater than or equal to 8.5 (defined as mean 12 month HbA1c greater than or equal to 8.5%)
3. Cared for in participating paediatric and adolescent diabetes clinics (defined as clinic specific for paediatric and/or adolescent diabetes conducted by a specialist or general paediatrician with an interest in diabetes)

An average of 40 -? 50 young people per clinic will be eligible to take part in the study with an expected recruitment rate of 25% based on our pilot study.

Previous inclusion criteria until 16/10/2012:
An average of 80 - 100 young people per clinic will be eligible to take part in the study with an expected recruitment rate of 25% based on our pilot study.

Exclusion Criteria

1. Subjects with significant mental health problems unrelated to diabetes that require specific mental health treatment
2. Subjects with significant other chronic illness in addition to diabetes that may confound the results of the intervention
3. Subjects with significant learning disability or lack of command of English sufficient to render them unable to participate effectively in the planned intervention. Note that there is research evidence from this population that the great majority of eligible young people from black or minority ethnic groups in this population have good command of English, although their parents may not. Given the wide range of ethnicities in the sample population, and given the importance of group dynamics to the intervention, it will not be possible to use interpreters to enable parents with poor English to participate. We will ensure that the validity of the study is maintained by the following:
3.1. Young people with good command of English but whose parents have poor command of English will be eligible to attend by themselves if they wish
3.2. Another relative who is one of the primary diabetes carers (e.g. sibling, aunt or uncle) who has good command of English may participate instead of the parents

While inclusive elsewhere, we will not recruit clinics that are unlikely to be able to recruit sufficient participants with a good command of English. We anticipate that this pertains to only one clinic within our sample area.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c between baseline and 12 months after intervention. <br><br>NB. It is not possible to directly evaluate the effects of the intervention on diabetes complications because of low incidence during adolescence.