Development, evaluation and implementation of a computer-based self-management programme for people with type 2 diabetes.

AimTo develop, evaluate and implement a computer-based self-management programme (SMP) for people with type 2 diabetes (T2DM) BackgroundDiabetes is one of the commonest long-term conditions in the UK (affecting about 2 million adults), causing substantial morbidity and premature mortality and costing the NHS about £9 billion per annum (c.10% of the total NHS budget). Structured education reduces the incidence of complications and NICE advises that all people with T2DM should have structured education at diagnosis with annual reinforcement. In 2006 only 11% of people with T2DM reported being offered such education suggesting an urgent need to find acceptable cost-effective ways of delivering it to large numbers of people. Computer-based SMP have considerable potential for meeting this need with evidence from systematic reviews suggesting they can improve knowledge and clinical outcomes. The use of new information and communication technologies (ICT) to improve health and health care is a central part of NHS policy and NHS Choices is already delivering a number of web-based SMP, although many of these have yet to be evaluated. Research plans (Fig 1- 8 Annex 4)Following MRC guidance our research applies a rigorous theoretical framework for developing and evaluating this complex intervention. In years 1 - 2 we will explore user perspectives of essential and desirable features of a computer-based SMP. Users include patients, their friends/family and primary & secondary care health professionals involved in diabetes care. We will use participatory design to develop a theoretically informed SMP which is linked with the patient electronic record but can also be accessed independently. The SMP will address recognized patient needs including information, emotional support and behaviour change support and will facilitate communication between patients and health professionals. The development process will ensure that the SMP is highly acceptable to all users and easy to implement in routine NHS practice. In years 3 – 5 we will undertake two parallel evaluations of the intervention in primary care: a phase 3 randomised controlled trial (RCT) and a phase 4 implementation study. The RCT will determine effectiveness and cost-effectiveness of the SMP, using HbA1c and health related quality of life as primary outcomes. The implementation study will explore what happens when the SMP is used in routine NHS practice, and what resources are needed for implementation. Research team and environmentThe team combines academic and clinical excellence of international renown in all necessary disciplines, including psychology (individual health behaviour change), sociology (implementation and organizational change), statistics, health economics, health services research and the clinical disciplines of diabetes, cardiovascular disease and primary care. We have extensive experience of developing, evaluating and implementing similar e-health interventions. The research will be based in the e-Health Unit in the Department of Primary Care at UCL. UCL is one of the top universities in the world and the Department of Primary Care performed excellently in the recent Research Assessment Exercise, leading to its inclusion in the prestigious NIHR School of Primary Care Research. The trial will be supported by the UCL Clinical Trials Unit.Anticipated outputs, outcomes and impactThis work will have a series of benefits to the NHS. Early deliverables include an understanding of essential and desirable characteristics of a computer-based SMP to inform the development of similar programmes for other long-term conditions. By end year 2 we will have completed an innovative, theoretically-informed SMP of proven acceptability to users through a process of participatory design. The intervention will provide easily accessible self-management education at low cost to large numbers of patients and a cost- and time-effective method to provide the annual reinforcement r