Details of HTA project in progress
Last updated: 1 February 2012 - Next update due: 8 February 2012
Research type: |
Primary Research (e.g. trial) |
Project title: |
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 education |
Project ref: |
06/44/05 |
Cost: |
£1,903,616 |
Chief Investigator : |
Dr Deborah Christie, Consultant Clinical Psychologist/Sen. Lecturer, Child and Adolescent Psychological Services, University College London Hospitals NHS Trust |
Project Website |
http://cascadestudy.com/ |
Start Date: |
May 2008 |
Estimated date of publication in HTA journal series: |
Early 2014. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
Managing diabetes within a full and active life is challenging for both children and young people. Despite parental support and 'expert' education many children & young people struggle to control their diabetes. Combining educational and psychological approaches can achieve engagement, motivation and long term-change, particularly in young people with poorly controlled diabetes that have not responded to other approaches. Children, young people and families have been involved in developing a structured psycho-educational programme with the UCLH diabetes teams. Four monthly group sessions will be offered to 3-4 similarly aged young people (and parents). The aim is to develop confidence in the use of flexible self management approaches including how to a)adapt the amount of insulin given, b)eat normally and c)manage daily challenges (e.g. exercise, illness, and holidays). The programme is acceptable to a broad range of families and can be delivered within a busy clinical service. For 170 families attending our clinics there has been a steady and consistent improvement in diabetes control that is maintained over time. In this evaluation, Clinical Nurse Specialists in 13 clinics, chosen randomly from 26, will attend training workshops. 520 children and young people (aged 8-16) and families from all 26 clinics will be invited to participate in the programme and a two-year follow-up. This will ensure sufficient numbers to be confident about the effect on control of diabetes (measured by HbA1c).We will look at how acceptable the programme was, ease of delivery, participation and impact on health related quality of life, self management behaviour, emotional, behavioural and family functioning and service use. The costs of the programme will be compared to the economic impact of improvements in HbA1c and reduced risk of long term complications. There are no risks in participation in the trial. In the short term, success in improving HbA1c may also improve general well-being and improve psychological function. In the longer term improvement in diabetes control is strongly predictive of reduced risk of later complications of diabetes. Clear written information would be provided and children and young people would be invited to give assent to participation. The trial will be guided by a multi-disciplinary group, including two public members, and focus groups of children & young people. The team includes members with significant research expertise who have run similar large scale trials and a clinical team nationally and internationally recognised as having significant expertise in the management of diabetes. |
Project Abstract: |
The intervention is a competency-driven, motivational and patient-centred structured intensive psycho-educational programme specifically designed to improve diabetic control, self-management and quality of life in children and adolescents. CASCADE aims to establish effective delivery and cost effectiveness of a structured intensive education programme using psychological approaches that maximise engagement, motivation and long-term change. A developmentally appropriate curriculum will teach adaptation of insulin dosage, normal eating and management of day to day challenges (e.g. exercise, illness) enabling flexible self management in diverse diabetes regimens. Children and young people (8-16 years) will complete the programme with their families. The primary outcome will be glycosylated haemoglobin (HbA1c) levels 12 months after the intervention. Secondary out-comes will include a 24 month follow up measure of metabolic control in order to evaluate maintenance of the intervention effect, as well as hospital admissions, hypoglycaemic episodes, self-efficacy, diabetes specific quality of life measures, family functioning and measures of emotional and behavioural adjustment 12 and 24 months post intervention. Health economic modelling will establish the cost effectiveness of the intervention and its applicability to the wider NHS. The study will use a multicentre cluster randomised controlled trial with integral process and economic evaluation. The trial and reporting will follow MRC guidelines for clinical trials and CONSORT guidelines. A strong multidisciplinary study team combines the expertise of established clinical and research teams that have a published record in successfully developing clinical research interventions and completion of large scale randomised trials. Our extensive experience in teaching and training will be used to identify the time and resources required to train members of the study centres which will be incorporated into the economic modelling process. The project will use in-post NHS staff to deliver the intervention. Even a small reduction in HbA1c will have an impact on long term risk reduction with potential costs saving to the NHS. |
ISRCTN* number: | ISRCTN 52537669 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN52537669 |
Project Protocol: |
Project protocol (pdf format, 11791 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1669 |
News feeds