Diabetes Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
Structure of CASCADE intervention: The intervention is delivered in 4 group sessions, delivered monthly over a 4 month period. Children will be grouped by age (either 8 -11 or 12 -16 years) and partic
Sponsors
University College London Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c between baseline and 12 months after intervention. NB. It is not possible to directly evaluate the effects of the intervention on diabetes complications because of low incidence during adolescence. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HbA1c at 24 months: the HbA1c measurement at 24 months post intervention will be examined as a secondary outcome assessing maintenance of effect 2. Economic evaluation: this will include within-trial cost-effectiveness analysis and a cost-utility analysis based on a model combining data from the trial with data from the literature. The perspective adopted will be that of the NHS, that is, the economic evaluation will only consider costs to the NHS and health benefits to patients 3. Psychosocial outcomes (using validated instruments appropriate for age): 3.1. Health related Quality Of Life (QOL): PedsQL with Diabetes module 3.2. Self-Efficacy in Diabetes scale 3.3. Diabetes Family Responsibility Questionnaire 3.4. Strengths and Difficulties Questionnaire (parent and child report versions) 4. Diabetes outcomes directly related to patient management: 4.1. Kaufman Competency level 4.2. Diabetes regimen (insulin delivery/number of injections/insulin types) 4.3. Hypoglycaemic episodes (frequency, severity) 4.4. Admissions to Hospital and reason (e.g. episodes of ketoacidosis, hypoglycaemia) 5. Diabetes outcomes indirectly related to patient management: knowledge and skills associated with diabetes 6. Compliance with intervention/control: 6.1. Attendance at intervention sessions 6.2. Service utilisation rate 6.3. Clinic attendance 6.4. Number of contacts with diabetes nurse specialists and diabetes teams Process evaluation: The study will incorporate an integral process evaluation, similar to other trials conducted by Social Service Research Unit (SSRU). The overall aims of this will be to: 1. Monitor the implementation (including extent of uptake) of the intervention in experimental clinics and any alternative intervention received by young people and families attending control clinics 2. Document factors influencing the implementation of the intervention 3. Identify components of the intervention which contribute to its effectiveness 4. Assess the acceptability o | — |
Countries
United Kingdom
Outcome results
None listed