Behavioural medicine for lower-educated patients with type 2 diabetes: the effectiveness and implementation of a tailored intervention in primary care

Behavioural medicine makes a healthy lifestyle part of the treatment and has the largest potential for diseases strongly associated with unhealthy behaviours. Type 2 diabetes mellitus (T2D) is such a disease, with behavioural risk factors such as physical inactivity, a ‘western’ diet and overweight and obesity being important modifiable drivers. For T2D, behavioural medicine implies: promoting healthy behaviour in order to achieve blood sugar control. Health care professionals wanting to include lifestyle in the treatment of patients with T2D, have a growing number of programmes, such as ‘Reverse Diabetes2’ at their disposal. However, available programmes do not fit the needs of a substantial part of patients, namely patients with a lower educational attainment. Many programmes are largely based on an individual approach, using cognitive and theory-based learning strategies, focussing on T2D and related health behaviours in isolation from the social context. These strategies have been proven to be less attractive as well as less effective for people with lower educational attainment. So when it comes to behavioural medicine for low-educated patients with T2D, health care professionals largely stand empty-handed. This is not only problematic for individual patients, but also from a public health perspective, given the large share of people with lower educational attainment among these patients. E.g. The multi-ethnic HELIUS study, showed that two-thirds of all patients receiving treatment for T2D in Amsterdam has a pre-vocational secondary education at most. Against this background, we previously developed a behavioural intervention for this particular group: Powerful Together With Diabetes (PTWD). This tailored group-based programme is unique in its use of appropriate learning strategies, and assistance in planning self-management, as well as its focus on mobilizing social support and reducing obstructive social influences. In a quasi-experimental design, we showed that the programme was attractive for the target population and that recruitment of patients through GP practices was feasible. Moreover, results of the trial indicated a positive effect on behavioural outcomes, including self-management, medication adherence and physical activity, as well as on interim outcomes such as exchange of social support and coping strategies. Thus, this programme has strong potential to fill the need for a behavioural medicine programme for low-educated patients with T2D. In the proposed study, we will investigate how the behavioural programme PTWD, can be implemented as a behavioural medicine intervention in the treatment for this target group. More specifically, our aim is twofold: 1. To assess the (cost-)effectiveness of the behavioural programme PTWD in low-educated people with T2D, including ethnic minorities, with HbA1c as the primary outcome. 2. To specify the conditions under which this programme can be implemented: we will define these conditions at the programme delivery level, such as setting, recruitment, capacity of group leaders; and at the organisational level, such as financing, quality assurance, and ownership of the intervention. To address these aims we will use a hybrid effectiveness-implementation design, that allows us to take a dual focus in assessing clinical effectiveness and implementation. First, we will test effectiveness (aim 1) in a quasi-experimental trial. We will recruit participants from GP practices in Amsterdam: 143 patients will be included in the intervention, with a matched control group (n=570, standard care) based on registration data. Glycaemic control (HbA1c) will be used as a primary outcome. Secondary outcome include medication use as well as use of health care services (primary, specialised). Intermediate outcomes include health behaviours and quality of life. Second, to be able to analyse whether the programme worked as intended and to specify the conditions for implementation, we will conduct a process evaluation (aim 2), using a mixed-methods design, including a qualitative study on patient experiences and conditions for programme delivery. Regarding the conditions for implementation at the macro level, we will use data from the process evaluation as well as other sources (interviews with stakeholders, literature etc.) to specify strategies for financing the intervention in primary care, as well as other conditions for programme governance (e.g. ownership) if implemented on a wider scale. The outcome of the project will be a detailed description of the behavioural programme and the conditions that need to be in place for its effectiveness. We will submit the programme to the portal ‘Loketgezondleven.nl’, for the qualification ‘good evidence for effectiveness’. The ultimate aim is to contribute to better overall health and quality of life of the large group of patients with T2D with lower educational attainment.