Extrait

Background and study aims This study involves people with learning disabilities who also have type 2 diabetes. There are high rates of poorly-controlled type 2 diabetes in adults with learning disability - this includes high levels of obesity and poor dietary habits; prescription medications that increase risk; and poor self-management skills. Finding those with diabetes, for service planning and for research purposes, is greatly helped in the UK by the fact that general practitioners (GPs) are required to maintain a register of all patients with diabetes. However, learning disability is less straightforward to define and identify, especially at the milder end of the spectrum. The aim of this study is thus, in phase 1, to develop and test a simple case-finding method to identify participants who have both mild/moderate Learning Disability and Type 2 diabetes who are not taking insulin and who might be suitable for the study intervention. Phase I of the study also aims to: 1. Develop a manual to aid supported self-management of diabetes 2. Assess the feasibility of delivering the intervention 3. Develop a simple measure of adherence to the manual 4. Develop procedures for determining and recording capacity and obtaining consent. The aims of Phase 2 of the study are to: 5. Estimate recruitment and retention rates 6. Assess the feasibility of collecting a range of outcome measures from participants and from medical records. 7. Test the effectiveness of the data collection forms developed 8. Assess the feasibility of delivering the intervention 9. Provide a detailed description of what treatment is delivered to each group. This work will enable development of a large scale study to test the clinical and cost-effectiveness of the intervention. Who can participate? Patients aged 18 and over who have type 2 diabetes which is not treated with insulin, have mild to moderate learning disability (not related to a disease acquired in adult life - e.g. adult-onset dementia), and live in the community (not in a hospital). What does the study involve? The first phase of the study involves developing best methods for identifying eligible people, and then conducting interviews with consenting participants. The interview includes questions about how they currently manage their diabetes, consent for access to health care records, and identification of a supporter who might help them if they take part in the second phase of the study. They are also asked whether they would be interested in taking part in helping with the development of the intervention, and being involved in the second part of the study. The intervention consists of 'supported self-management' materials, developed by reviewing the literature and materials that are already in use to help people manage their diabetes. Participants who are willing to be involved in this process are consulted to further develop the intervention. In the phase 2 of the study participants are randomly allocated to receive either the supported self-management intervention that has been developed in phase 1, or usual care. What are the possible benefits and risks of participating? It is hoped that some participants may benefit directly from the study materials. Very few risks are anticipated at any point in the study, but any changes in mood or behaviour are monitored. Where is the study run from? Diabetes services in primary and secondary care in Bradford, Leeds and Wakefield will be involved. The study researcher will be based at the University of Leeds (UK). When is the study starting and how long is it expected to run for? February 2013 to January 2016 Who is funding the study? NIHR Health Technology Assessment Programme (UK) Who is the main contact? Dr Louise Bryant [email protected]

Critère d'inclusion

• Diabetes, Learning disabilities

Liens

• isrctn
• ictrp