Title: Non-pharmacological approaches to improving diabetes outcomes
Funder: Department of Health (England)

Abstract: Aims:The overarching aim of our programme is to test the need for and efficacy of non-pharmacological interventions to improve self-care skills, and thereby outcomes, for people with diabetes, in a variety of diabetes situations important in morbidity, mortality, quality of life and health expenditure. Background: Despite proven efficacy of strategies to reduce diabetes complications, nearly half of all patients with diabetes have suboptimal diabetes control. A major contributor to this may be reduced self-care skills resulting in impaired adherence to all aspects of diabetes care. The underlying hypothesis is that psychological and social factors impact on self–care skills and diabetes outcomes and are targets for effective intervention. Research plans Four projects address different clinical settings using mixed epidemiological, randomised controlled trial (RCT), and qualitative methodologies. Project 1, a prospective cohort study of ~1700 people with recently diagnosed Type 2 diabetes, will assess the association between psychological and social factors on glycaemic control and other cardiovascular risk factors at 2 years. This will provide important data for devising interventions to support people with diabetes in effective self-care thereafter. Projects 2, 3 and 4 are guided by the MRC framework for the evaluation of complex interventions and focus on people at high risk of complications. Key characteristics for each intervention are that they are brief, cost-effective, deliverable in primary and secondary care and accessible to a socially and ethnically diverse population. The interventions are deliverable by existing members of the health care team trained in a standardised, readily disseminated format, with built-in quality assurance. The interventions have either evidence of benefit in other lifestyle related diseases, e.g. obesity, or have suggestive but not conclusive evidence of benefit in diabetes. Project 2 is a phase 3 RCT in people with Type 2 diabetes for more than five years and persistent poor control. It will test the cost–effectiveness of Motivational Enhancement Therapy (MET), a client centred, counselling style that facilitates behaviour change, to improve diabetes control. Project 3 is a phase I & 2 complex intervention in people with diabetic foot disease, combining MET techniques, educational theory, public health strategies and focus groups to improve outcomes. Project 4 is a preclinical and phase 1 proof of principle study in patients with type 1 diabetes and recurrent disabling hypoglycaemia. The study will model and pilot, using in-depth interviews, an intervention grounded in standard psychological and educational theory, aiming to reduce risk-taking behaviours in those with severe hypoglycaemia. All projects include a health economic assessment and will devise the training tools for rolling out each intervention using existing diabetes health care professionals and local resources. The Research Team is a multidisciplinary collaboration of diabetes and mental health professionals, primary and secondary care service delivery managers, a public health epidemiologist, an health economist, a statistician, user representatives and expert patients. Our diabetes service has one of the best-defined mental health links in the UK. The team has experience in RCTs and a track record of recruitment into cohort studies and RCTs in our community. The Research Environment is at King’s College Hospital (KCH), with Guy’s and St Thomas’ (GSTT) and the PCTs of Lambeth, Southwark & Lewisham, co-ordinated through the local Diabetes Clinical Network. Our academic partner is King’s College London, both the School of Medicine and the Institute of Psychiatry. The local community has high ethnic mix and severe social deprivation and is at very high risk of type 2 diabetes mellitus. Access will be facilitated by liaison with the Starnet programme and the creation of a district wide diabetic eye screening register. Anticipated outputs. The identification of key factors with a modifiable impact on self–care skills will inform the delivery of health care in diabetes but also have relevance to all chronic disease management. The development of effective interventions which can be implemented across the NHS and deliver a 1% difference in HbA1c, a fall in systolic blood pressure and improved lipids should translate into a 30-40% reduction in risk of diabetes complications in these high risk groups. Public Involvement. The project team is linked to thriving patient participation and expert patient groups and senior members of the PCT responsible for public health. A Patient Reference Group from a broad spectrum from the local community, with appropriate training, will advise on the study and oversee the projects. Focus groups will be formed as appropriate. Results will be disseminated through the media, relevant local publications, presentations to community programmes and expert patient groups


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: METABOLIC AND ENDOCRINE