Title: Healthy Living Diabetes - Long-term Independent National Evaluation (HED-LINE)
Funder: Department of Health and Social Care

Abstract: Background Type 2 diabetes (T2DM) has serious health implications and is costly for the NHS. Appropriate glycaemic and blood pressure control, and changes in lifestyle to reduce weight can decrease these risks. People often find it difficult to make (and maintain) changes. Structured T2DM education programmes are available but attending groups is not suitable for everyone. Healthy-Living is a web-based self-management programme offering information, behaviour-change content and support for emotional well-being. An RCT has shown it is feasible, acceptable, effective and cost-effective. Now the NHS wants to see if there are similar benefits from a roll-out across England. Aim: Evaluate the real world implementation of Healthy-Living. Objectives: 1) Examine the extent to which people with T2DM start Healthy-Living and continue to use it, and whether engagement varies by patient characteristics; 2) Determine the effectiveness of Healthy-Living in changing clinical outcomes; 3) Assess the barriers and facilitators affecting the implementation of Healthy-Living at clinical and organisational levels, the fidelity of implementation and acceptability to patients and the NHS; 4) Establish the cost-effectiveness of Healthy-Living compared with usual care when rolled out across England, from an NHS and personal and social services perspective. Methods Uptake: using data from the Healthy-Living programme linked to a primary-care dataset, the National Diabetes Audit (the Linked Data) we will use multiple logistic regression and linear regression to estimate the association between patient demographics, baseline clinical measures, T2DM-treatments, co-morbidities, referral-type and various measures of participation in the programme. Effectiveness: Matched cohort study using two years of Linked Data (baseline and follow-up). Referred people will be matched 1:5 to non-referred using demographic and health characteristics. Multiple and logistic regression models will estimate the association between being referred and HbA1c (primary) and other clinical outcomes. Sub-group analyses will explore population characteristics that potentially benefit most/least from the intervention. A &ldquo;dose-response&rdquo; approach will model exposure to Healthy-Living and its association with outcomes. Implementation: Barriers, challenges and enablers to implementation of Healthy-Living, and its integration within existing NHS T2DM management care pathways will be explored using semi-structured interviews with local NHS implementation leads and general practices, and documentary analysis. Service Delivery and Fidelity. We will provide an estimate of what &ldquo;dose&rdquo; of intervention participants received, how they received it, and consider how this impacts differently on diverse populations. Methods: coding of online content for behaviour change techniques and self-management tasks, compared to plans; analysis of Linked Data to examine exposure to online content; semi-structured interviews with patients to understand engagement, enactment and acceptability. Budget Impact Analysis. An economic evaluation informed by modelling to estimate longer-term benefits and costs. We will use an existing validated simulation model, the UKPDS OM2 model to extrapolate T2DM risk factors and predict long-term outcomes expressed as life expectancy, quality-adjusted life-years (QALYs), and NHS/PSS costs. Impact and Dissemination We will share early findings with the Healthy-Living team to shape future implementation and seek opportunities for wider dissemination to patients and clinicians, involving patients to ensure the most important findings are disseminated clearly.

Lay abstract: Background Type 2 diabetes is a common health condition that can cause further health issues and reduce people s quality of life. Treatment is essential, but it costs a lot of money. If people with type 2 diabetes take medication as and when recommended and make some sensible changes to their lifestyle (e.g. stop smoking, take more exercise, lose weight), they can help reduce their personal risk of greater health issues. There is evidence that Diabetes education courses can help people manage their type 2 diabetes and reduce the risk of further complications. However the take-up rate of the face-to-face courses has been very low. The NHS is introducing a new web-based service named Healthy Living , which they hope will be more accessible for those with work and family commitments. The new service will be offered throughout England. The people introducing Healthy Living need to know if it really will work and whether it is a good use of NHS resources. We have designed a research project which should help answer these questions. Research plan We will analyse information gained from Healthy Living, and general practice records, to see what kind of patients are invited onto the programme, and whether they complete the programme. We will match people referred and not referred to the programme and report on whether referred patients show improved outcomes, such as healthier levels of blood sugar and losing weight, compared to those who were not referred to the programme. We will also see if some patients have better outcomes than others and try to find out why. We will interview NHS clinical staff and managers responsible for the Healthy Living programme throughout England. We will ask them how they set up the service and what things they think help or hinder the programme. We will analyse information gained from Healthy Living and interview patients to see how well the Healthy Living programme is delivered to patients and check that they receive all of the self-management materials they need to succeed. We will suggest what might be improved. We will also look at whether the programme offers good value for money. All this information will be reported back to the people running Healthy Living so they can make improvements as they go along. Our team has the necessary skills and experience to do this research as we have done similar work in the past on other national programmes. The research should benefit patients by testing whether Healthy Living is (practically) effective, and by providing information to improve the service. People with experience of diabetes will play an important role in managing the research and helping us to identify the benefits to patients and the NHS.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;8.2 HEALTH AND WELFARE ECONOMICS;7.1 INDIVIDUAL CARE NEEDS
Health categories: METABOLIC AND ENDOCRINE