Extrait

Background and study aims Type 1 diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The skills necessary to manage type 1 diabetes are delivered through structured education programmes such as the Insulin Training and Teaching Programme (ITTP) in Germany and the Dose Adjustment For Normal Eating (DAFNE) programme in the UK and Ireland. These programmes are virtually identical as DAFNE was closely modelled on ITTP. With the disease, treatment and education similar across Germany, the UK and Ireland, why do diabetes outcomes differ so much across European countries? To date there have been few comparisons of outcomes following structured education programmes across countries. This study will try to identify the key ingredients of successful self-management of type 1 diabetes through a cross country comparison. Currently the data suggests that German people do better than people in the UK following structured education programmes in diabetes. This study will help identify why that is. Is it to do with the cultural or healthcare context that these structured education programmes are delivered in, or is to do with how individual people value their own health? This study aims to explore how values, institutions, health care organisation and health care structure impact on the behaviour of patients and on their ability to self manage their type 1 diabetes following structured education in Germany, the UK and Ireland. Who can participate? Patients aged 18 or over with type 1 diabetes who are currently enrolled for a DAFNE programme in one of the participating centres (Sheffield Teaching Hospitals and University Hospitals of Leicester). What does the study involve? Two DAFNE centres in the UK are involved in this study. All aspects of one course in each of these centres are observed by the researchers, including how the course is delivered, where the course is delivered, and formal and informal interactions between course participants and educators. Sixteen patients are approached to participate in an interview lasting about 60 minutes before completing DAFNE and about 6 months after DAFNE to explore their attitudes, experiences and behaviours. Four educators at these hospitals are also approached to participate in one in-depth interview each. What are the possible benefits and risks of participating? This study involves no intervention. It is a low to non-risk study. Participants (both educators and patients) and centres involved in the study will be anonymised to ensure participant data remains confidential. Participation should cause no adverse effects, pain, discomfort, distress or changes to lifestyle. To minimise any intrusion or inconvenience participants will be invited to suggest a time and venue for the interviews. Light refreshments will also be provided. Transcripts will be made available to each participant for their approval and comments. Any topics that are particularly sensitive, embarrassing or upsetting will be brought up at the discretion of the participant only, not by the researcher. The participant does have to discuss anything they do not wish to. Medical records will not be required. Where is the study run from? The study will take place in the outpatient diabetes centres of participating hospitals (Sheffield Teaching Hospitals and University Hospitals of Leicester) (UK). When is the study starting and how long is it expected to run for? May 2011 to June 2012 Who is funding the study? Health Research Board (Ireland) Who is the main contact? Mary Clare O'Hara [email protected]

Critère d'inclusion

• Type 1 Diabetes

Liens

• ictrp
• isrctn