Extrait

Background and study aims Diabetes is a condition associated with many long-term complications. It affects a large number of people and its management is costly to the NHS. People with diabetes need to be actively involved in managing their condition and self management of diabetes is sometimes complex. Patients receive advice in consultations with healthcare professionals. However, patients do not always discuss things which concern them in these consultations, perhaps because of perceived limited time or embarrassment. PACE-D is a tool which has been developed for this study. It is designed to help people with diabetes to identify any areas that they think are important to discuss in their routine consultation. We want to test whether using the PACE-D tool to produce an agenda helps people to play a more active role in their consultation, and whether this in turn helps people to manage their diabetes. Who can participate? Adults with type 1 or type 2 diabetes are eligible to participate (excluding women with gestational diabetes and people with insulin pump). What does the study involve? Participants are randomly allocated to one of two groups. One group will complete the PACE-D questionnaire and the other will attend their routine appointments as normal (control group). After completion of the PACE-D questionnaire, a list of the participant’s main concerns (agenda) is produced and this is taken into consideration. On three occasions (prior to the consultation, three months and six months later), each participant will complete a standard postal questionnaire and provide a blood sample (as a measure of glucose control). To analyse the content of the sessions and clinical encounters, a small number of these sessions will be audio recorded with the permission of all relevant parties. What are the possible benefits and risks of participating? It is possible that there may be slight distress to some individuals. There are questions in the questionnaire booklet that may cause slight distress or embarrassment. We will minimise the impact on participants by providing those who experience such distress with the contact details of appropriate organisations that can provide support. Where is the study run from? This study is conducted at the Royal Devon and Exeter NHS Foundation Trust, UK and Plymouth Hospitals NHS Trust, UK. The study takes place at routine outpatient appointments with a consultant diabetologist with 60 participants per site. When is study starting and how long is it expected to run for? The study started in May 2013 and will continue for two years. Who is funding the study? This research is funded by the National Institute for Health Research (NIHR), UK. Who is the main contact? Dr Julia Frost [email protected]

Critère d'inclusion

• Topic: Diabetes Research Network; Subtopic: Both; Disease: Diabetic Control

Liens

• isrctn
• ictrp