Digital health interventions in chronic kidney disease: levelling the playing field?

ABSTRACT

Digital health interventions (DHIs) have long been thought of as a convenient way to deliver aspects of healthcare and broaden access to services. For patients with chronic kidney disease (CKD), DHIs designed to improve health literacy, self-efficacy and health-related behaviours such as physical activity, diet and adherence have been developed and are being tested, but their translation into clinical practice will be challenging. While DHIs potentially have broad reach, it is increasingly clear that patients from lower socio-economic and educational backgrounds, minority ethnic groups, elderly patients and those who face digital poverty are the least likely to access and benefit from DHIs, when they are precisely the patients who stand to gain the most. This article discusses the potential for DHIs to level the playing field for patients with CKD as well as the steps researchers, clinicians and developers should consider ensuring DHIs are developed, in collaboration with patients, to be inclusive and effective, as well as strategies that should be considered during development to support translation into practice.

INTRODUCTION

Chronic kidney disease (CKD) is an increasing international public health problem. Kidney disease is currently ranked by the World Health Organization (WHO) as the 10th leading cause of death internationally and deaths attributable to kidney disease are projected to continue to increase until at least 2030 [1]. While progression to end-stage kidney disease is relatively uncommon [2], morbidity and mortality related to CKD is high, with cardiovascular disease being the most common cause of death [3]. While some patients with CKD are managed in specialist secondary care services, most patients with earlier-stage CKD are managed in primary care, where there is limited or no access to services for patients with CKD relating to lifestyle or patient education. Associated adverse health outcomes and symptoms start in early-stage CKD [3, 4], but patients are often unaware of their diagnosis [5]. Moreover, neither patients nor primary care physicians may be aware of what can be done to improve CKD symptoms and health outcomes.

Cardiovascular disease for patients with CKD is strongly associated with clustering of traditional and non-traditional risk factors and as CKD becomes more severe, traditional strategies to mitigate excess cardiovascular risk become less effective [6, 7]. Many of the processes that drive cardiovascular disease in patients with CKD are potentially modifiable. Lifestyle modifications, including improving physical activity levels, targeted exercise rehabilitation interventions and appropriate diet, can modify the cardiovascular risk profile for patients with CKD. Despite this, physical activity levels for many patients with CKD are low and engagement with healthy lifestyle behaviours is limited [8]. Additionally, there is limited awareness of the health implications of CKD [9–12], despite clear relationships between patient health literacy and activation (the knowledge, skills and confidence to effectively manage personal health and care) and effective self-management or engagement with healthy lifestyle behaviours [13] and health outcomes [14].

Digital health interventions (DHIs), particularly to support the management of patients with chronic diseases, are not a new concept [15, 16]. Digital solutions have long been seen as hypothetical and cost-effective ways of delivering aspects of healthcare, including the detection and screening of disease as well as treatment and prevention [17]. A well-designed DHI should be personalisable for the end user and have broad reach, reducing inequality of access, making them an attractive solution for delivery of aspects of healthcare, particularly relating to patient education and lifestyle-related behaviours given the highly variable availability and quality of these services. It has been acknowledged by the WHO that we must learn to harness the power of DHIs and digital technologies more generally to improve healthcare delivery for all [18], but these technologies in themselves are not an end—rather, they are tools that may be used to improve and promote health, particularly for the most disadvantaged. A number of DHIs have been shown to be beneficial for delivery of patient (and healthcare worker) education on lifestyle, physical activity and psychological well-being for a variety of patient groups [19–24]. However, history has also shown us the many challenges to successful development and implementation of such resources. It is also abundantly clear that while theoretically DHIs could help ‘level’ opportunities for participation and engagement, there are significant barriers to engagement that may relate to the design of the intervention/technology or to their access for particular individuals or groups, whether that is due to language, literacy, culture, age or socio-economic reasons [25]. Furthermore, even when DHIs are shown to be beneficial, their translation into widespread clinical practice is often limited because the pathways to implementation and for commissioning are poorly understood and difficult to navigate. That DHIs are often developed as a partnership between clinicians, researchers and technology companies adds a further layer of complexity with regards to commissioning of or paying for services.

Access to evidence-based resources to improve patient knowledge and ability to self-manage aspects of health as well as to physical activity and lifestyle programmes designed for the complex needs of patients with CKD are needed. Some resources exist, but are not widely available and access to appropriate education and lifestyle resources is usually governed by local availability and expertise. Increased awareness and sharing of resources where they exist should be a priority, but for the development of new DHIs, specific considerations need to be given to the development and implementation of such programmes. Here we discuss the potential for DHIs to level the playing field for patients with CKD in terms of access and outcomes as well as the challenges and common pitfalls in their development and implementation.

Conceptualising digital health interventions that influence behaviour

It has been suggested that DHIs that seek to influence behaviours through lifestyle, education or psychological support/intervention are best developed within a framework that considers certain characteristics [26]. Attention must be paid to the theory that underpins the intervention, with development (and delivery) by individuals with appropriate and relevant expertise, the behaviour change techniques they will employ (e.g. goal setting, prompts, rewards, self-monitoring) and the mode(s) of delivery of the intervention (e.g. online, mobile app, messaging). Additionally, we suggest a fourth essential component: the inclusion of patients and stakeholders in co-development and design, as well as throughout testing and refinement. With regards to the design of the technology, it has also been suggested that DHIs that seek to influence lifestyle behaviours are more likely to succeed if they provide elements of health education and allow for personal goal setting and self-monitoring [27].

Lin et al. [24] showed how a cognitive behavioural therapy (CBT)-based health app could be successfully used to improve the likelihood that people would stop smoking. This DHI was designed to develop psychological empowerment of individuals using CBT through a mobile phone app. The intervention in this programme was grounded in appropriate theory, developed by experts, with input and iteration from users and with ‘gamification’ (the use of game design elements in non-game contexts) to harness natural tendencies towards play to enhance engagement. Similarly, the It's Life monitoring and feedback tool [21] showed that for patients with type 2 diabetes and chronic obstructive pulmonary disease, the addition of an online self-management, monitoring and feedback tool in addition to traditional counselling led to improvements in physical activity compared with traditional counselling alone. This DHI was co-developed with patient partners and was iterated following feasibility and pilot work [28–30] and careful consideration was given to appropriate models of implementation to bridge the translational gap [31].

Co-development of DHIs at each stage with patient partners has been shown to be crucial to the success of lifestyle-related DHIs, particularly in combination with usability testing [32, 33]. The MyDESMOND programme is an online self-management programme to support patients with type 2 diabetes to manage their health. This programme was co-developed with patients using intervention mapping, a six-step framework often used to develop behaviour change and education interventions, a process that typically involves conducting a needs assessment, specifying program outcomes and objectives, designing the program with application of appropriate theories, refining the program development, establishing adoption and implementation and evaluating the plan.

Intervention mapping is one example of a development framework that can be used to support development of a complex intervention, but other frameworks may be equally appropriate. What is important is that an appropriate framework is chosen and applied to support development. In the above example, this careful approach has meant MyDESMOND is available for many patients across the UK as a commissioned service.

Several DHIs have been successfully developed to improve the diets and dietary outcomes of the general population and children with obesity [19, 20], but a number of dietary DHIs have not been as successful [34, 35]. The technological aspects of each of these DHIs can be considered broadly similar, but successful interventions tended to be developed with extensive patient input, with rigorous testing, development and refinement, emphasising the fact that the creation of a marketable technology alone will likely be ineffective.

Challenges in development and implementation of DHIs

Even when DHIs are proven to be effective at modifying lifestyle and health behaviours, important factors limit their uptake and use. Even in successful trials of DHIs, a significant proportion of the eligible population declines to participate [24]. This is a common issue, not just for trials testing DHIs, and is explained (at least in part) by the wide variety of barriers for different patients and patient groups to participation in clinical research generally. While the WHO acknowledges that DHIs may be a way to improve access to healthcare for the most disadvantaged, engagement from many disadvantaged groups is poor.

Patients from lower socio-economic groups have poorer health outcomes and are more likely to engage in risky lifestyle behaviours than patients from higher socio-economic groups [36]. These are exactly the patients who stand to benefit most from lifestyle-related DHIs. But even when interventions that have been shown to improve the health of patients with long-term conditions have been tested in patients of lower socio-economic status, the effects are small or non-existent [37]. This is because most of the interventions have not been appropriately developed to account for the different needs of these patients and a one-size-fits-all DHI is unlikely to be suitable or effective for patients of lower socio-economic status [25]. Similarly, patients from minority ethnic groups, particularly South Asian and Black individuals, are more likely to develop kidney disease [38] and chronic health conditions such as cardiovascular disease [39] and type 2 diabetes [40] with poorer health outcomes. Despite this, only a small proportion of DHIs are developed with consideration of the needs of patients of differing ethnic backgrounds, with some seemingly not giving any regard to the needs of patients who face any kind of health inequality [41]. Challenges of language, accessibility and culture are often not addressed during development, marginalising even more from access to interventions that could potentially be of enormous benefit with downstream effects on successful implementation.

Additionally, ‘eHealth literacy’ and access are often not considered during the development of DHIs, even when the interventions are developed for underserved communities such as those from lower socio-economic backgrounds or minority ethnic groups [42]. This inequity of access related to the skills or means to access to DHIs is often described as the ‘digital divide’ and is an increasingly recognised public health concern [43]. Perhaps predictably, the characteristics of individuals who tend to have lower digital literacy and access are the same as those who are marginalised by traditional health inequalities, i.e. lower socio-economic status, increasing age, minority ethnic background and lower educational attainment. To develop and implement DHIs successfully, we must not overlook the need to develop eHealth literacy to improve access for marginalised groups in addition to developing tools to enable access for those with traditional health inequalities. For patients with CKD, this is particularly relevant to older patients and patients from minority backgrounds.

The final challenge is the implementation of DHIs. DHIs are often developed as collaborations between clinicians, academics, charities and commercial organisations. These partnerships should be encouraged due to the expertise that is required for resource and platform development as well as thorough, objective testing. For DHIs to be sustainable beyond the research and testing phase they require consistent funding to support running and development costs. To achieve equity of access, these costs cannot and should not be passed on to the end user as a fee for service, and if DHIs are shown to be effective, then often developing teams approach health service providers to negotiate licencing of a particular DHI for their patients. Providers, rightly, have a duty to ensure value for the services they commission, and simply demonstrating clinical efficacy is unlikely to be enough. Increasingly, to ensure the last translational bridge to implementation is crossed, in addition to clinical efficacy, DHIs may also be expected to demonstrate cost-effectiveness, sustainability plans, beneficial effects on quality of life measures and reductions in healthcare utilisation costs. The models of ‘commissioning’ of these services are different across different healthcare systems, between primary and secondary care services and between private and public providers, all with different requirements, structures and resources. It takes time to gather these data and teams should be mindful of the specific data commissioners will be most interested in for the commissioning of different DHIs, so these are factored into development and testing. One final essential consideration for any DHI is safety. Developing teams must know the coding standards required by the healthcare service in which the intervention may be used, be able to demonstrate the code has been written to these standards, be prepared to pay for this to be tested by an external company and have a clear policy to deal with the meta-data acquired through use of the DHI, even if no patient-level data are acquired. If patient-level data are handled by the DHI, an even greater level of scrutiny and security is inevitable to ensure safe storage and processing of data in line with the particular health service policies and European Union general data protection_ regulations.

The implementation of ‘successful’ DHIs invariably falls on the developing teams, and with so much to navigate it is easy to see why so many effective resources never make it to mainstream use. A better awareness of these challenges will support researchers, clinicians and developers to build the key steps to implementation into development, testing and refinement phases, as beyond this point it is often too late.

Lifestyle and health behaviour DHIs for patients with kidney disease

The rationale for developing DHIs that improve lifestyle and health behaviours for patients with CKD are clear. DHIs that can support the very specific needs of patients with CKD could have enormous impacts on health outcomes and well-being, particularly if they are available to patients with early-stage disease who are most often managed in primary care without input from specialist kidney teams. As in other conditions, it is crucial that DHIs are co-developed with patients and that relevant issues of access are addressed to ensure they can be accessed by those who need them most [44].

Two such resources have been developed and are currently undergoing testing and refinement. The Kidney BEAM and the My Kidneys and Me platforms have been developed over the last 3 years as complementary resources, partly in response to the coronavirus disease 2019 pandemic. Kidney BEAM is a multimedia platform to support self-management relating to physical activity and well-being, while My Kidneys and Me is a multimedia platform designed to develop health literacy and patient activation and to support lifestyle modification through improved self-efficacy. Both resources have been developed by experts in close partnership with patients, are grounded in appropriate theories and were developed following the processes and recommendations outlined in this article [45–47]. They are currently in the final stages of evaluation as part of multicentre randomised clinical trials in ways designed to support implementation and future commissioning. Additionally, both resources will be refined on completion of the respective trials based on extensive feedback and qualitative work with trial participants, patients who declined to participate and key stakeholders and stakeholder groups.

What remains to be seen is what the kidney community will make of these resources beyond the research and testing phase if they are shown to be clinically effective. Historically, clinicians and opinion leaders have placed limited importance on prioritising lifestyle and educational interventions that support health outcomes for patients with kidney disease. The development of this pair of DHIs (and others) should offer hope to patients and teams who care for patients with kidney disease that equitable access to such interventions may be possible in the not-too-distant future.

AUTHORS’ CONTRIBUTIONS

M.G.B. prepared and drafted the manuscript. A.S. and S.G. offered comments and revised. M.G.B. revised and finalised the manuscript which all authors agreed prior to submission.

CONFLICT OF INTEREST STATEMENT

S.G. is Chief Investigator of the Kidney BEAM trial. A.S. is Chief Investigator of the SMILE-K trial. M.G.B. is a co-investigator on the Kidney BEAM and SMILE-K trials.