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

Lead Research Organisation: University of Leicester
Department Name: Diabetes Centre

Abstract

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.

Technical Summary

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.

Planned Impact

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.

Publications

10 25 50
 
Description Twelve healthcare professionals received training to deliver the EXTEND programme and 98 participants were recruited to the study and received the EXTEND programme. Retention to the study was high at 100% in Mozambique and 94% in Malawi. Overall, improvements were observed in median HbA1c (-0.9%), mean cholesterol (-0.3mmol/L), mean blood pressure (-5.9mmHg systolic and -6.1mmHg diastolic) at 6 months in addition to improvements in indicators of wellbeing (problem areas in diabetes [PAID] and self-efficacy in diabetes).

It is feasible to deliver a culturally, contextually and linguistically adapted EXTEND programme in two lo-middle- income countries. It is also feasible to set-up and recruit to a study to evaluate its effectiveness in a study setting. The EXTEND programme was acceptable with positive biomedical and psychological outcomes but requires formal testing in a definitive randomised controlled trial with cost-effectiveness. Challenges exist in scaling up such an approach in health systems that do not have the resources to address the challenge of diabetes.

Also, based on our qualitative study, 66 people took part in the focus groups/telephone interviews including people with T2D who participated in the EXTEND programme; healthcare professionals, EXTEND educators, EXTEND trainers, and stakeholders. Key findings suggest that diabetes self-management behaviours and implementation of self-management programmes are influenced by factors on an individual and interpersonal level (i.e. lack of knowledge, cultural beliefs, financial constraints); on an organisational level (i.e. education and training for healthcare professionals); on a community level (i.e. promoting education via radios and TVs, engagement with rural and urban areas); and on a policy level (i.e. development of integrated and dedicated diabetes service). Overall, the EXTEND self-management programme helped build knowledge around diabetes management. A self-management programme could reduce the burden experienced in health systems in Sub-Saharan Africa. In the future, EXTEND could be incorporated in the development of diabetes training and dedicated diabetes services in Sub-Saharan countries, to act as an educational tool for both people living with T2D and healthcare professionals.
Exploitation Route The outcomes of this funding have been taken forward by submitting for further funding to test an RCT trial. The funding was submitted to the MRC NIHR Joint Call in Global Health in 2019 which was unsuccessful.

Currently, we are in discussions with our collaborators in Malawi and Mozambique to proceed with further funding with MRC to test an RCT trial.

Resources developed from the EXTEND study are put to use by partners in Guinea Bissau to improve the self-management of their population.
Sectors Education,Healthcare

 
Description Collaboration with Ghana 
Organisation Korle Bu Teaching Hospital
Country Ghana 
Sector Hospitals 
PI Contribution There is minimum availability of diabetes self-management education and support programmes in Ghana. In collaboration with our partners in Ghana we culturally adapted resources and materials developed from the EXTEND study to support the work in Ghana. In addition to this, we also provided remote training to a group of local clinicians to equip them with core facilitation skills and knowledge to be able to deliver face-to-face self-management education sessions in their setting. Due to the pandemic, the training was delivered virtually. To showcase the work that we have conducted with our partners, we are in the process of drafting papers to showcase the work that we have done together.
Collaborator Contribution Our partners have contributed to this collaboration with ongoing communication and input with the cultural adaptation work and delivery of the training. Our partners worked closely with our team to ensure that the resources that were being adapted were tailored to the Ghanaian population. Even though the training to clinicians was done remotely, a lot of work was required from our partners to ensure that the training was ran smoothly (i.e. logistics of training, set up of rooms etc).
Impact Outcomes: Upskilling local clinicians to deliver self-management education sessions to people with type 2 diabetes Adapt content, language, images to tailor resources to a Ghanaian setting Output: Work in progress to publish collaborative paper showcasing the work that we have done
Start Year 2021
 
Description Partnership with Geneva University Hospitals, Switzerland 
Organisation Geneva University Hospitals
Country Switzerland 
Sector Hospitals 
PI Contribution Our research teams has supported the University of Geneva in the delivery of the project entitled: "Improving the management of diabetic patients in Guinea Bissau" through the: - Provision of access to its Intellectual Property Rights contained within the DESMOND EXTEND curriculum, content and materials. - Access to educator training provided by the LDC, as may be required, and subject to further discussion and negotiation - Access to additional academic, research, or other services/resources, as may be required, and subject to further discussion and negotiation We will collaborate with our partners in future joint and shared publications where applicable and seek future joint grant and funding opportunities where possible. The aim is to increase community accessibility of structured education programmes in Guinea Bissau.
Collaborator Contribution Based on this partnership, our partners will utilise resources developed from our EXTEND study, to help improve self-management in people with type 2 diabetes in Guinea Bissau. Specifically our partners, will aim to: -Improve the lives and health outcomes of people who live with type 2 diabetes and those identified as being at risk of developing type 2 diabetes in Guinea Bissau -Taking into account cultural differences, any development or adaptation of the study programme will remain consistent with the learning philosophy underpinning the DESMOND programmes
Impact None to report yet
Start Year 2019
 
Description African Diabetes Congress 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Professor Melanie J Davies was invited to present at the African Diabetes Congress in Cameroon (April 2019). The design and preliminary results of the EXTEND project were presented in addition to the issues around this diabetes facing Sub-Saharan Africa
Year(s) Of Engagement Activity 2019
 
Description Final trial steering group meeting UK 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact The final trail steering committee meeting was hosted in the UK at the Leicester diabetes center. Co-investigators from Malawi, Mozambique, South Africa and Switzerland were in attendance chaired by Professor Davies. Tours of Leicester, the hospital and the department were provided.
Year(s) Of Engagement Activity 2019
 
Description Knowledge exchange 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Social scientist whom we are working with on EXTEND from Malawi visited the Leicester Diabetes Center for 1 week. Training was provided and supervision re: qualitative research methods specifically coding data. They attended presentations and met the diverse range of researchers and disciplines within the LDC. This researcher and our senior resaercher (UK Psychology) are co-writing the qualitative results paper.
Year(s) Of Engagement Activity 2019
 
Description Presentation to the Ugandan Ministers of Health 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Dr Emer Brady presented the EXTEND study to members of the ministry of health from Uganda and Ms Bernie Stribling presented the background to diabetes self-managment education
Year(s) Of Engagement Activity 2018
 
Description Press Release (UK) 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact A press release of the EXTEND program and members of the research team from the UK taking the trip over to Mozambique to train educators
Year(s) Of Engagement Activity 2018
 
Description Qualitative research in Mozambique 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Three researchers from UK, two from Switzerland conducted a series of focus groups with 1) Clinicians delivering diabetes care, 2) Policy makers and stakeholders, 3) Patients with diabetes who received the self-management education and 4) the educators who delivered the education. This was to provide data on 1) final iterations of curriculum, 2) pathways and barriers to implementation, 3) changes to the delivery of the research project i.e. removal of questionnaires. Networking activities and tours of hospital, outpatients and diabetes charity provided
Year(s) Of Engagement Activity 2018
 
Description Second Trial Steering committee - Mozambique 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Five researchers including Professor Melanie Davies (Clinical academic), two researchers from Switzerland, and two from Malawi attended the trail steering committee hosted in Maputo Mozambique. This included the PI and local researchers in Mozambique.
Year(s) Of Engagement Activity 2018
 
Description Trial Steering committee meeting - South Africa 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Five researchers from the UK, 1 Professor from Malawi, Researcher (Dr) from Switzerland and researcher from Mozambique attended the first trial steering committee meeting in South Africa chaired by Prof from South Africa. The rest of the UK team joined via TC. The UK team also met with and discussed research specialties with the wider South African team.
Year(s) Of Engagement Activity 2017