Extrait

Background and study aims: We would like to improve the way that people with type 2 diabetes manage their condition. Previous research has shown that people with type 2 diabetes can benefit from attending education programmes. This study will assess the benefits of a new programme called 'Steps to your healthy future' or 'Steps' for short. Steps is a group education programme which lasts for 12 months. The aim of the programme is to support patients with type 2 diabetes in their everyday lives and help them to manage their condition. The programme will help patients to learn and find out more about their whole body and what steps they can take to improve their diabetes mamangement and overall health. Who can participate? People who have had type 2 diabetes for between 1 and 10 years , who are aged between ages of 18 and 70 years. What does the study involve? To assess the Steps programme we need to compare it with normal diabetes care. This means that half of the people taking part in the study will receive the Steps programme and the other half will continue to receive their normal diabetes care. Whether participants receive the Steps programme or not will be decided randomly at the beginning of the study, the process is rather like tossing a coin. 1. If participants are randomly selected to join the intervention arm of the study they will receive the Steps programme straight away. 2. If participants are randomly selected to join the control arm of the study they will receive normal diabetes care for 12 months and then they will be invited to attend the Steps programme at the end of the study. Taking part in the Steps programme involves attending group sessions that last for 1 hour. The programme will cover topics like nutrition, physical activity, improving posture, understanding marketing and media influences on health, understanding health habits, creating changes in behaviour and managing relationships. The Steps programme sessions will take place in small groups with a maximum of ten patients per group. Patients will be invited to bring a friend, family member or carer along to the sessions. An important factor of the Steps programme is that it is not run by medical professionals such as doctors or nurses. Instead it is delivered by health and fitness experts. The sessions will take place once a week for the first 10 weeks and then after this initial period, there will be four follow up sessions which will be once every 10 weeks. This gives a total of 14 sessions over a period of 12 months. Taking part in the study means that participants will be asked to attend data collection sessions at baseline when joining the study and then again after 3, 6 and 12 months. At the data collection sessions participants will be asked to fill in a questionnaire booklet and have some measurements including height, weight, waist, hip and neck circumference recorded. Selected members of the research team will look at sections of participants' medical notes to obtain recent measures of HbA1c (glucose control) and cholesterol. Participants will also be given the opportunity of taking part in two home interviews with a member of the research team. What are the possible benefits and risks of participating? Participants' contribution to the study will help us to improve diabetes services for people in the future, although participants may not receive any direct benefit themselves by taking part in the study. We are not aware of any risks connected with this study, but you may like to know that medical research is covered for mishaps in the same way as for patients undergoing treatment in the NHS, in that compensation is available if negligence occurs. If you have any concerns or complaints about the study or the way it has been carried out, you can contact the research team project manager: Mrs Sopna Choudhury. If you wish to complain formally, you can do this through the normal complaint mechanisms available to you through the NHS by contacting your local Patient Advice and Liaison Service (PALS). Where is the study run from? Birmingham and Black Country Collaboration for Leadership in Applied Health Research and Care and the University of Birmingham. When is the study starting and how long is it expected to run for? Recruitment for the study began in December 2012. Participants will start to receive the Steps programme in early 2013, and the study is expected to run until April 2016. Who is funding the study? National Institute for Health Research, UK Who is the main contact? Mrs Sopna Choudhury [email protected]

Critère d'inclusion

• Type 2 Diabetes

Liens

• ictrp
• isrctn