Randomised controlled trial on the effect of social support on disease control, mental health and health-related quality of life in people with diabetes from Cote dIvoire: the SoDDiCo study protocol

Background and rationale

It is currently estimated that more than 24 million people from sub-Saharan Africa have diabetes, with two-thirds unaware of their status.1 According to a recent survey conducted in the south-central part of Côte d’Ivoire, diabetes and pre-diabetes prevalence were 8% and 47%, respectively, in people aged 35 years and above.2 Diabetes mellitus (DM) and the severe complications resulting from delayed diagnosis and poor glycaemic control contribute importantly to disability and, hence, burden of disease. Long-term consequences of poorly managed diabetes include blindness, kidney disease, peripheral neuropathy, amputations, stroke and heart attacks as a result of microvascular and macrovascular complications.3

Depression is ranked by WHO as the single largest contributor to global disability (7.5% of all years lived with disability in 2015).4 In low-income and middle-income countries (LMICs), resource allocation for mental disorders is sparse, partly reflecting their stigmatisation and poor recognition by non-specialist health workers. The Lancet Commission on Global Mental Health and the 2030 Agenda for Sustainable Development have pointed out the importance of integrating mental health services with care for non-communicable diseases.5 6 Unaddressed mental care needs may be a barrier to the successful control of diabetes in LMICs. Depression and diabetes often coexist and exhibit a mutually exacerbating relationship.7 Indeed, depression can adversely affect physical functioning, behaviour and quality of life in people with diabetes and accelerate disability trajectories. Self-management is an important aspect of diabetes control. Yet, the somatic features of depressive symptoms (eg, lack of energy and sleep disturbance) often interfere with adopting necessary healthy behaviours (eg, medication management and exercise). This can result in a vicious cycle of poor glycaemic control, inactivity and low mood.8 Symptoms of acute hyperglycaemia, including fatigue, nausea, frequent urination and recurrent infections, also may cause or exacerbate depressive symptoms.

According to the social capital theory, trusting relationships and reciprocal social exchanges are key determinants of the health and well-being of people. Proposed mechanisms for this effect include exposure to health-related behaviour norms and attitudes, psychosocial mechanisms (such as self-esteem and sense of obligation), access to information, material assets and personal support (through reciprocal social relations).9 Social capital refers to the resources that individuals and groups access through their social connections.10 It includes community networks (voluntary, state, personal networks and density); civic engagement (participation and use of civic networks); local civic identity (sense of belonging, solidarity and equality with other members); reciprocity and norms of co-operation (a sense of obligation to help others and confidence in return of assistance); and trust in the community.11 The study of social capital in public health research comprises network capital approaches that focus on the resources embedded within a person’s social network and social cohesion approaches that measure social capital as the cognitive and structural resources available to social groups. Cognitive social capital covers aspects such as trust, norm, reciprocity and perception of the social environment. Structural social capital includes extent and intensity of social face-to-face encounters, online participation and mobile phone use. Three main settings have caught the attention of researchers on social capital: family or household, neighbourhood and workplace.

Research has shown associations with lifestyle factors for social networks,12–15 cognitive or structural social capital9 16 17 and both aspects in parallel.18 19 Low social capital measured at an individual or community level is also associated with depression, although inconsistently.20–25 A limited number of mostly cross-sectional studies have investigated the relevance of social capital in people with diabetes.26 27 Associations of several social capital domains with patients’ quality of life,27 28 glycaemic control29–31 and self-care capacities32 33 were observed. Studies on the links between social capital and diabetes in LMICs are generally lacking. A primary responsibility of diabetes treatment lies with the patient as self-care includes diet, exercise and, in some cases, medication and treatment adherence. Given the behavioural demands placed on a patient with type 2 diabetes, social support may be an important factor in glycaemic control. Those with adequate support systems may be more compliant with the challenging diabetes regimen and have better control over their condition.34 Many type 2 diabetes management behaviours occur outside of the clinical environment and require daily support and resource mobilisation. Consequently, interactions with family and household members, which enable positive health behaviours, may shape one’s health outcomes.31 Comprehensive evaluation of a social support-based intervention as a potentially cost-effective tool for diabetes control in LMICs is of high relevance. There is a pressing need for evidence on the impact of such interventions on self-management, lifestyle and depression in specific social-ecological contexts, taking into consideration important effect modifiers such as social capital, gender, age and socioeconomic status and applying interventional longitudinal designs.

Study objectives

The primary objective of the social support on disease control, mental health, and health-related quality of life in people with diabetes in Côte d’Ivoire (SoDDiCo) trial is to test the efficacy of a social support intervention (added to routine clinical care) on the longitudinal course of glycaemic control, mental health and health-related quality of life, assessed over a 1-year period, among adult people with type 2 diabetes presenting at the Centre Antidiabétique d’Abidjan (CADA), Institut National de Santé Publique (INSP), Abidjan, the economic capital of Côte d’Ivoire.

The secondary objectives of the study are to assess the modification of the aforementioned intervention effects by social capital. In addition, we will assess at baseline the distribution and associations of mental health indicators and social capital among all participants. Figure 1 presents an overview of the objectives of the SoDDiCo trial.

Figure 1
Figure 1

: Design of social capital, depression, and diabetes control in SoDDiCo Trial. Over 12 months, newly diagnosed and eligible diabetes patients presenting at the Centre Antidiabétique (CADA), INSP in Abidjan, Côte d’Ivoire will be randomized to either control arm (routine care) or intervention arm (routine care + social support). Patients in both trial arms will be followed-up over a 1-year period to evaluate the effect of social support intervention on diabetes control, mental health, and health-related quality of life (objective 1; O1). Potential modification of the intervention effect by baseline social capital features will be explored (O2). Furthermore, the characterization of the study sample by their mental health and social capital features, and their correlations at baseline, will be explored (O3). CADA: Centre antidiabétique d’Abidjan at Institut National de Santé Publique. INSP: Institut National de Santé Publique

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