EXTending availability of self-management structured EducatioN programmes for people with type 2 Diabetes in low-to-middle income countries (EXTEND)

Type 2 diabetes (T2D) is a long term condition where the body doesn't manage its blood sugars (glucose) properly. This can result in the levels of glucose in the blood being quite high. If the body is exposed to high levels of glucose in the blood for long periods of time it can injure the vascular system - both the large and the delicate blood vessels in the body. This can lead to a number of complications such as blindness, kidney damage, damage to the nerves and heart attacks. It is really important when someone is diagnosed with T2D they are supported and taught how to manage their condition to prevent these complications. Globally, the number of people with T2D is increasing with approximately 415 million people currently living with this condition. Eighty percent of people who have T2D live in low-to-middle income countries. LMICs do not have the financial resources, or infrastructure to effectively manage this increasing patient population specifically as they are already stretched dealing with the infectious diseases that are common in these countries i.e. HIV, TB. Therefore, there is great need for inexpensive but effective treatment options for patients.

Patients with diabetes manage their condition on a daily basis themselves. International experts state that patients with diabetes should be taught how to do this; structured education programmes (SEPs) equip people with diabetes with self-management skills. SEPs have been shown to improve diabetes related outcomes in patients, such as blood glucose and wellbeing. An educated and empowered patient can work more effectively with their doctor to improve and maintain better control of their condition. SEPs are usually delivered to groups of patients in the community by trained non-medical educators and thus are a relatively inexpensive 'therapy'. In the UK researchers have developed and tested a SEP called DESMOND which has been shown to improve well-being, adherence to medication, and weight loss amongst other positive outcomes. DESMOND and is currently delivered in over 100 sites in the UK and is also used in in Southern Ireland, Australia and Qatar. To date no SEPs for diabetes have been tested in LMICs. Therefore, this provides a great opportunity to take a diabetes SEP that is proven to be effective and is widely attended in one country and transfer it to another.

The UK research team in collaboration with clinicians and academics from South Africa, Mozambique and Malawi propose to culturally adapt and translate (linguistic adaptation) the DESMOND programme for use in two LMICs - Mozambique and Malawi. The collaborative will then test the feasibility of the adapted SEP in both locations. Data will be collected on the number of people that are invited, respond to invitation, the number that attended the programme, their diabetes control (using point-of-care-testing), blood pressure and their opinion and experience of the programme. Collectively, this information will be used to help us design a formal study after the end of this programme of work. An SEP adaptation tool-kit (detailed instructions) will be developed so that other organisations can take SEPs that work in one country and adapt it for themselves. An implementation model will also be developed again allowing other organisations/health services to implement - that is make SEPs available on a large and sustainable scale. Both of these will be freely available for the public. To ensure the success of this work we will work closely with the local diabetes associations, we will train local healthcare professionals and people from the local community to deliver the education which means that they can continue to do so well after the end of this study.

Globally, it is estimated that 415 million people have diabetes (90% type 2, T2D) and that three quarters of people live in Low-to-middle income countries (LMIC). Urbanisation and an ageing population are considered to be the main drivers for the increasing prevalence of chronic non-communicable diseases such as T2D. Indeed, LMICs health services are are increasingly under pressure with this "double jeopardy" of communicable disease (e.g. HIV) and chronic NCD. Significant development challenges in LMIC are lack of healthcare infrastructure and wide disparities in access to high-quality healthcare due to poverty, both of which impact on diabetes management. Subsequently, there is a demand for effective and cost-effective treatment options for people with T2D. Structured Education Programmes (SEPs) are a potential solution for this scenario. Leading international health organisations promote self-management as the cornerstone of diabetes care, and recommend SEPs for all people with T2D. There are no SEPs available is LMIC such as Malawi and Mozambique that have proven effectiveness and cost-effectiveness. We propose to take a SEP, developed in the UK, with proven effectiveness and cost-effectiveness and undertake a cultural and linguistic adaptation of the programme in Malawi and Mozambique. Through development of infrastructure and training, using a multi-disciplinary approach we will build the capability of these LMICs to deliver such programmes. We will conduct feasibility studies at each locality to explore accessibility and acceptability. We will build new methodological knowledge and develop a SEP adaptation toolkit and implementation model for SEPs in LMIC. These will be made freely available. The data and knowledge gained from the feasibility studies will inform the development of a protocol for the formal evaluation of each SEP in their localities. It will also form the basis for attracting future funding to secure the legacy of this work.

TThe potential impact of the work described in our 'Case for Support' is far-reaching; by designing effective and cost-effective methods for the implementation and adaptation of culturally appropriate structured education programmes (SEPs) . This addresses the key health challenge that is the burden of T2D in LMICs, and facilitates capacity building in of LMICs to deliver and sustain such SEPs. By working to improve T2D control with an established South Africa-based network (CDIA) that reaches into Mozambique and Malawi, the work will address economic development, health, and welfare of these two countries at the level of the individual, whilst providing wider near-term economic and societal benefits to LMICs. This work is further strengthened through collaboration with Dr Beran who has a track record for conducting quality research in Mozambique in the field of diabetes. Group SEPs are an ideal intervention for LMICs as they are cost-effective, provide peer-support, and can be delivered by lay community members meaning that they can be delivered in remote settings. Addressing the development need of improved T2D management will lead to increased and sustainable human resource capacity, for example; investing in, and up-skilling, local healthcare workers and community members to deliver SEPs; employing research staff locally and contributing technical assistance (including clinical and research methods) from the UK, South African and Swiss partners. Further, the patient will directly benefit from increased awareness of diabetes, improved psychological well-being, self-management skills, they will become empowered and participate with their doctor in effectively managing their condition. They will contribute to the adaptation of the SEP ensuring it is culturally appropriate. Collectively this will have a direct impact on the local economy and the potential to have national economic impact through savings to the health service due to improved patient outcomes.

By developing a toolkit and implementation model increases the reach of this research - other LMICs will be able to freely access these tools and use them to conduct similar work in their own country - furthermore they are not 'disease specific' but relate to SEPs in general and therefore can be applied to other chronic conditions. This is desirable since SEPs are often developed in higher income countries and so adaption and translation are required to allow equitable access to these programmes, at least for the foreseeable future. This approach is also likely to be more effective and efficient than continually developing new SEPs as work that has already been conducted is shared between health systems, allowing for SEPs, and thus the health systems within which they sit, to be more responsive to the needs of the users.

This work will generate further research through the data and knowledge collected throughout the feasibility studies. Indeed a key output is a protocol for the formal evaluation of the SEP in the target population that will be used to attract further funding. This lends to sustained international collaborative working and learning within and between the participating academic and clinical institutes, who will continue to work together. Working in conjunction with local diabetes association's we will further raise awareness of diabetes and the importance of self-management nationally. Evidence will be available to researchers, policy makers, and stakeholders on the feasibility, potential barriers and facilitators of SEP use in health systems in the partner countries.