Title: Supporting people with type 2 diabetes in effective use of their medicine through a system comprising mobile health technology integrated with clinical care
Funder: Department of Health and Social Care

Abstract: Background Type 2 diabetes affects 2.9 million people in the UK. Treatments to reduce risks of complications from type 2 diabetes are effective if taken as intended. Concerns about medicines and difficulties in taking them regularly, whether intentional or unintentional, are common. Some services to help are available, but evidence of their effectiveness and cost-effectiveness is weak. These services may not be right for everyone, and are not designed for repeated use. Not everyone has access to this extra help. Importance In addition to the burden of preventable death and disability, the cost of non-adherence with diabetes treatments has been estimated at &pound;100 million a year in avoidable treatment costs. Understanding and improving this situation could make a major contribution to health and NHS costs. Need for Research Systematic reviews do not provide strong evidence to support the wider use of current approaches to developing interventions to support adherence. Brief messages delivered at a wide-scale and low cost via digital health systems added to usual care have been shown to be effective in improving health for some conditions and are a promising approach to the problem. Past and current research Systematic reviews of text-messaging to support adherence to treatment and mobile health interventions in diabetes identify some effective interventions. There are few trials testing the impact of brief messaging in type 2 diabetes; they do not have systematically developed interventions and are at risk of bias. Recent trials of SMS text-messaging for cardiovascular risk prevention and blood pressure lowering have shown clinically relevant changes in outcomes compared with usual care. Research Plans We will ask patients, clinicians and experts in behaviour change what sort of messages are likely to be relevant and acceptable for people starting and continuing taking a diabetes medicine. We will examine predictors of non-adherence in a retrospective primary-care cohort using routinely collected electronic health record data. We will explore, using qualitative methods, the added value of tailoring messages based on personal preferences, the type of medication prescribed, duration of treatment and timing of medication collection. We will carry out a feasibility study to inform decisions about the final design of the intervention and the trial to evaluate it. We will test the intervention in a randomised clinical trial and linked health economic study to estimate the extent of benefit and costs. We aim to understand how the intervention might work and be implemented by interviews with patients and health care staff, and using quantitative measures based on psychological constructs. Research team Members of this research team have previously worked together to develop new interventions and test them in trials funded by Oxford NIHR Biomedical Research Centre and others. These include interventions to help people take their medicine more regularly and mobile-phone based interventions for people with diabetes. The research team will work in partnership with Patient Groups, NHS Trusts, Research Networks, and the Health and Social Care Information Centre to deliver this research. Research Environment Applicants are based at leading academic institutions with strong training programmes for early-career clinical researchers and methodologists. The lead Department has a silver Athena SWAN award. There are strong links with patient involvement groups to ensure a strong PPI reference group for the programme, well developed clinical research networks to support recruitment, and good links with an Academic Health Sciences Consortium specifically interested in facilitating digital health care projects. Outputs This research will provide evidence about how to give support to patients, in addition to their usual care, using a range of messages targeting a wide range of the factors that can contribute to stopping or underusing medicines. This research will offer a model for technology-based self-management support that could be extended to other aspects of diabetes care, and other long-term conditions. Impact If effective, this intervention could reduce the burden of complications and increased costs associated with under-use of diabetes medicines. A coordinated system for automated reminders could improve satisfaction with health services and offer a model for technology-based self-management support. This could be extended to other aspects of diabetes care, and other long-term conditions. Ethical Implications We will ensure messages are acceptable, use secure links and will encrypt data for transmission. This research would involve people who have given their full consent to take part. We will convene an independent stakeholder group to review governance and information technology issues and to advise on how best to carry out the research so that it can be more easily implemented in the NHS.

Lay abstract: Type 2 diabetes is a lifelong condition that causes a person's blood sugars to become too high. It can cause serious long-term health problems. In the UK, more than 1 in 16 people have diabetes, and it takes up 10% of the NHS budget. Medicines to lower blood glucose, blood pressure and cholesterol, when taken as intended, can stop complications developing. Concerns about starting medicines and difficulties in taking them regularly are common. The National Institute for Health and Care Excellence (NICE) advises health professionals to ask patients about concerns with medicine. However, it is uncertain whether this support is consistently available or right for everyone, or how far it helps improve use of medicines. Advice, information and prompts for a wide range of medicine-related concerns and problems can be offered by sending brief messages to mobile communication devices (e.g. text-messages) in addition to usual care. This can be done for large numbers of people at low cost. Sending brief messages can improve health, but more research is needed so they work better and are relevant to different groups of people. People with type 2 diabetes have special concerns about the ways medicines might affect them. The small number of studies so far using brief messages for type 2 diabetes do not provide convincing evidence that they are helpful. This programme of work draws on patient suggestions that mobile phones could be used to help with reminders about medicine use. A panel of eleven service users will play a key role in the research. They will guide our work, review our research findings and advise on how the intervention can best be used in practice. We will find out which types of messages are most useful for people starting and taking a diabetes medicine. We will examine whether messages can be tailored to the individual using routinely available NHS data. We will also explore if it is valuable for patients to decide which types of messages they want to receive and respond to. We will test the system in a large clinical trial to estimate the extent of benefit and costs, and identify difficulties that might be encountered in practice. We will make sure messages are acceptable and use secure links and encrypt data. This brief messaging system will offer a unique range of messages targetting the many different causes of non-adherence (not taking medicines as intended). In this trial we aim to test whether the intervention has benefits for patients taking their medication more regularly so that it can be implemented within the NHS. This research could offer a model for technology-based self-management support that could be extended to other aspects of diabetes care and other long-term conditions.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: METABOLIC AND ENDOCRINE