Chronic kidney disease (CKD) affects approximately 5% to 7% of people living in the United Kingdom [1]. People with CKD have an increased risk of morbidity and mortality, which is largely attributable to cardiovascular disease [2]. Progressive kidney damage can lead to end-stage kidney disease (ESKD), where kidney replacement therapy (ie, dialysis or transplantation) may be needed [3]. However, most people with reduced kidney function never progress to ESKD but, nevertheless, live with significant poor health and high symptom burden [4]. Many individuals with nondialysis CKD are diagnosed and managed by primary care clinicians with infrequent or no input from kidney specialists in secondary care or other members of the multidisciplinary team (eg, specialist or nonspecialist nurses or allied health professionals) [5]. These individuals are mainly required to self-manage their condition, which involves balancing the medical, emotional, and psychosocial consequences of living with CKD and any additional comorbidities with their day-to-day responsibilities [6,7].

The Chronic Care Model has identified self-management as an essential component in chronic disease management to empower patients to take a more active role in their health [8]. Self-management is a complex set of processes and tasks involving the following: (1) use of an individual’s knowledge (education), skills, and confidence in managing their disease; (2) the ability to identify and access resources and support; and (3) learning to cope and live with the condition, including the impact on an individual’s life and the emotional consequences [9-11]. The goal of effective self-management support is to identify strategies that can help individuals manage their condition(s) while leading full, active, and productive lives. For people with CKD, specific self-management behaviors range from understanding and adhering to medication, health and symptom monitoring, and making lifestyle modifications (eg, increasing physical activity and eating an appropriate diet), which reduce cardiovascular, CKD, and general health risk factors [12].

Effective self-management requires appropriate knowledge, skills, and confidence to manage one’s own health and care; this is termed patient activation [13]. However, significant deficiencies in CKD awareness and knowledge among people with CKD have been identified [14-16], with many reporting limited or no understanding of their condition and little or no awareness about how to manage their health [17]. Individuals living with CKD, who are managed in primary care, are often unaware of their diagnosis and the detrimental effect that poor risk factor control (such as hypertension and diabetes) may have on their health [18].

Evidence suggests that primary health care providers infrequently discuss CKD with their patients and that the quality of these discussions is limited [19]. Furthermore, self-management support and education through face-to-face interactions in clinical settings are minimal [6,20-22]. For clinicians, barriers to successful education include lack of time and clinical confidence combined with competing priorities [17]. For people living with CKD, the complex nature of CKD information, limited awareness, health literacy and numeracy combined with the lack of readily available and understandable information and reduced readiness to learn form the greatest challenges [17]. Clearly, innovative approaches to support self-management in people with CKD are urgently required.

Although various self-management interventions have been evaluated, many are not theoretically driven or evidence-based, nor are they informed by patient preferences [22]. Digital health interventions (DHIs) are an efficient and effective method of providing interventions to improve knowledge and self-management behaviors and to actively involve individuals in their care, resulting in improved outcomes for people with long-term conditions [23]. Implementation barriers often associated with face-to-face interventions, such as time and transport, can be addressed using DHIs, which provide more accessible, acceptable, tailored, and interactive information and support [24,25]. When developing evidence- and theory-based DHIs, it is essential that appropriate methods are adopted to ensure effective implementation [26].

Despite DHIs becoming more readily available for people with CKD, few are theory-based, and the development strategies and processes are unclear. Conversely, DHIs in other long-term conditions, such as type 2 diabetes, have appropriately recorded and systematically communicated their development processes. An example is MyDESMOND, which adapted a face-to-face diabetes self-management program (Diabetes Education and Self-Management for Ongoing and Newly Diagnosed, DESMOND) [9] and translated it onto a digital platform [27]. The adaptation and development of MyDESMOND were guided by the intervention mapping (IM) framework.

The aim of this paper is to provide an overview of the process used in the systematic development of “My Kidneys & Me” (MK&M), a digital self-management program for people living with nondialysis CKD.

The MyDESMOND platform interface and features [27] were adopted for MK&M (justification is described in the Results section). The developed MK&M materials and content (presented in the Results section) were mapped onto the existing MyDESMOND platform [27]. Key components of the intervention were selected based on the feasibility of adopting and adapting the existing MyDESMOND platform to suit MK&M content and materials within the resource constraints.

For the priority-setting workshop and the booklet workshops, the PPI members provided written informed consent. DIMENSION-KD was granted national research ethical approval (18/EM/0117). All patients provided informed written consent, and the study was conducted in accordance with the Declaration of Helsinki. The SMILE-K study was fully approved by the Research Ethics Committee-Leicester South (17/EM/0357). All participants are required to provide informed consent online.

Given the successful development and implementation of the MyDESMOND program [27,83,84], it was advantageous to use the preexisting and established MyDESMOND platform to host the MK&M program. MyDESMOND is an award-winning program on a quality-assured platform, which is known to be well accepted and effective [83]. The MyDESMOND platform was built using progressive web apps and is accessible on any digital device (tablet, desktop computer, and smartphone) and operating system. The system was developed using the Zend framework and MySQL database. The app includes an app programming interface built with Zend, which is used to manage data between the AngularJS progressive web app and the database. The MyDESMOND platform hosts several evidence-based web-based self-management programs, including programs for people at risk of or with type 2 diabetes. The existing MyDESMOND programs are used throughout the United Kingdom and Australia. These MyDESMOND programs have gained accreditation from Quality Institute for Self-Management Education and Training. The Quality Institute for Self-Management Education and Training (QISMET) defines good practice in self-management education [85]. MyDESMOND has been successfully reviewed by Organisation for the Review of Care and Health Apps (ORCHA) [86], an independent leading digital health reviewer that assesses digital health programs against the latest standards and guidelines that cover clinical/ professional assurance, data and privacy, and usability and accessibility. MyDESMOND also conforms to the Digital Technology Assessment Criteria (DTAC) for health and social care. This is a new national baseline criterion used to ensure that the latest standards within digital health systems are being met. It covers clinical safety, data protection, technical security, interoperability, and usability and accessibility standards and is used for the commissioning of digital health technologies [87]. The MyDESMOND platform is flexible to easily allow for additional programs to be added and adapted. Adding the MK&M content and materials to the MyDESMOND platform [27] and adapting the existing platform to suit the program needs provided a cost- and time-efficient approach for developing our digital intervention. In addition, the MyDESMOND platform meets many National Health Service (NHS) requirements and quality standards, which would enable the future implementation of MK&M in clinical practice.

We mapped the developed MK&M content as closely as possible to the preexisting features already available on the MyDESMOND platform [27]. For example, we mapped the “Learn About” and “How To” sessions onto the preexisting “Learning” and “Booster” sessions on the platform. Figures 3 and 4 present examples of the sessions available. The MK&M goal-setting materials were mapped onto the MyDESMOND “Decision Maker” feature. We adopted the health (eg, blood pressure, shape, and healthy eating) and physical activity (eg, step counting) trackers that were already available on the MyDESMOND platform [27], as these were perceived to adequately meet the needs of people with CKD.

Although we were able to adopt the interface and features of the MyDESMOND platform [27] and map most of the MK&M content and materials onto it, there were some key MK&M components that were missing. Thus, we further adapted the platform to suit our needs. This involved creating and realizing a bespoke CKD symptom (detailing 13 common symptoms identified by people with CKD not receiving kidney replacement therapy [88]) (Figure 5) and a bespoke strength tracker, which were conceptualized during the codevelopment of materials and content in phase 1. Links to strength training materials, including flashcards and demonstration videos, were embedded within MK&M. To aid individuals’ understanding of the program and navigation through the platform, we also created a welcome video detailing the aims of the program and a screencast (ie, digital video recording of our computer screen, including audio narration) explaining how to navigate the program and the key features available. The finalized MK&M materials and content were uploaded onto the platform by the MyDESMOND digital team. Finally, we added an MK&M-specific launch page to the MyDESMOND platform, as shown in Figure 6. Usability (functionality, navigation, and interactivity) and experience testing of MK&M was conducted through think-aloud interviews to identify potential areas for refinement (manuscript in preparation).

Self-management has been identified as a top priority by individuals with nondialysis CKD, their caregivers, clinicians, and policy makers [89]. The concept of patient empowerment is integrated in the “NHS Long Term Plan,” which aims to support people with long-term conditions to improve self-management skills and provide access to resources [90]. Here, we have described the codevelopment of a theory- and evidence-based digital self-management program for people with CKD, guided by the IM framework and the MyDESMOND development process [27].

The formation, participation, and engagement of the multidisciplinary planning group and PPI group were valuable as it enabled knowledge, experiences, and visions to be shared. The development process was guided by the inputs from HCPs and the PPI group, with both groups reviewing and refining the program content and materials and the method of delivery alongside the researchers. This ensured that the program was appropriately designed and relevant to people with CKD and that people with CKD and HCPs support MK&M. Having input from the MyDESMOND and IMPACT teams greatly facilitated the development of MK&M, as learning first-hand from their experiences in developing MyDESMOND [27], and adapting their processes, was invaluable. In addition, the ability to map our own program onto the MyDESMOND platform was advantageous.

The IM process helped the rigorous development of MK&M and ensured that we explored our program goals in depth and were able to specify what it was that we needed to change and which method and practical applications would elicit the desired change. This ensured that MK&M, similar to MyDESMOND, was underpinned by a strong theoretical framework and evidence-based foundation. Using IM enabled a meaningful analysis of the underlying mechanisms that are hypothesized to affect the desired intervention outcomes by enabling the explicit linking of interventional components to theory, which should result in improved outcomes for the target population [91]. The use of behavior change theories and techniques to determine the anticipated behavior change ensured a pragmatic application of change methods.

The IM framework provides a comprehensive approach that clearly articulates the development process [34], which allows for more transparency in the design of the intervention to others outside the development team. The process may be different for different interventions, and each step of the framework allows for the adaptation of the different requirements of the specific population, setting, and nature of the intervention [34]. Using IM enabled us to produce an intervention that is potentially efficacious and acceptable and can be implemented in CKD. The needs assessment conducted in step 1, alongside lessons learnt from our previous work, provided us with a clear understanding of the different key components that needed to be incorporated into MK&M. Identifying the desired outcomes of MK&M ensured that appropriate content and materials were designed to address our program goals.

Aside from using IM to develop interventions, the approach may aid clinicians in assessing the suitability of an intervention, its applicability to their setting and population, or what change may need to occur to the intervention to enhance its suitability [92]. The dissemination of the development of complex interventions offers clinicians more detailed information on which they can base their decision regarding the implementation of these interventions [92].

To our knowledge, this is the first systematically developed theory- and evidence-based digital self-management program for people with nondialysis CKD in the United Kingdom. Another digital intervention for people with CKD, called Kidney Beam, has been developed in the United Kingdom to provide support for exercise, physical activity, and emotional well-being [93]. Similar to MK&M, Kidney Beam is theory informed and guided by the Behaviour Change Wheel. The full development process, application of theory, and selection of BCTs have yet to be published. Unlike MK&M, which provides a holistic approach to self-management, encompassing the core tasks alongside the key processes, Kidney Beam aims to specifically address exercise, physical activity, and emotional well-being. Results of the feasibility study were promising and showed good levels of engagement, with 43% of individuals signing up to the platform and completing at least one exercise class [93]. Similar to MK&M, Kidney Beam is currently being evaluated in a randomized controlled trial to evaluate the feasibility, clinical value, and cost-effectiveness of the Kidney Beam program delivered as part of clinical care [93]. It is to be hoped that MK&M and Kidney Beam will provide complementary options for future kidney care.

Digital self-management programs for people with CKD have also been developed in other countries such as Canada [94] and the United States [95]. There are similarities and differences between these programs. Like us, Donald et al [94] and Markossian et al [95] co-designed their program with stakeholders, involving people living with CKD and their relatives, clinicians, researchers, and graphic designers. Although there are similarities in methodologies, both MK&M and “My Kidneys My Health” [94] developed a web-based self-management resource, whereas Markossian et al [95] developed a mobile app. In our program, we used the IM framework to guide the development, whereas Donald et al [94] used the “Knowledge-to-Action” framework to guide the multiphased activities for determining CKD patient self-management support intervention. It is not clear what framework was used to guide the development of the mobile app by Markossian et al [95]. Like us, Donald et al [94] and Markossian et al [95] are evaluating their programs in a study, which will further provide an insight into the acceptability and engagement of the digital programs and identification of patient-reported outcomes and potential factors for implementation.

The efficacy of MK&M in improving patient activation and subsequent self-management behaviors is currently being evaluated in a multisite clinical trial in the United Kingdom, with results expected in 2023 (protocol paper published elsewhere [96]). Patient activation is considered the cornerstone of effective self-management in CKD, as it encompasses all the necessary ingredients for effective self-management (ie, knowledge, skills, and confidence) [45]. Findings from the trial will provide the first step in determining whether MK&M is effective in increasing patient activation and promoting self-management behaviors in people with nondialysis CKD. In addition to evaluating MK&M, we also look to implement MK&M in renal services as a part of clinical care. Currently renal services are undergoing redesigning as a part of the Renal Service Transformation Programme [97]; consequently, we are conducting preliminary work before implementing MK&M into clinical care to ensure MK&M can be successfully embedded within the new model of care.

The inclusion of a stakeholder steering group comprising multidisciplinary professionals and PPI members with a variety of experience and expertise, who were involved in the codevelopment of MK&M, was vital to the successful development of MK&M. The PPI group was key in identifying the needs and preferences of people with CKD; however, the PPI members were predominantly White British, female, and well educated. Consequently, as our PPI group may not be representative of the CKD population, MK&M may not be suitable for all individuals with CKD. Successful use of MK&M is likely to require a certain level of health literacy and activation. It was developed in partnership with individuals who participate and engage in activities such as PPI and are therefore likely to be more engaged than the typical patient. The generalizability and applicability of MK&M will be established and addressed during the evaluation, refinement, and implementation phases of the program.

Although the IM approach provides a useful planning template to develop a tool that is theoretically grounded and evidence-based, it is very time consuming. The process described in this paper took approximately 2 years to complete, which was longer than initially anticipated; this was partly because of the COVID-19 pandemic, where members of the participatory steering group had competing clinical interests that took priority during this period, and the time taken to adapt a preexisting platform to suit our needs. Despite this, others have also reported similar experiences when using IM [36,98,99].

Despite the ambition, and initially setting out, to coproduce MK&M, it was not feasible owing to the COVID-19 pandemic. The inability to meet face-to-face during this period influenced the level of involvement of the members of the participatory steering group; moreover, clinical members were required to work on the frontline of the United Kingdom’s NHS, and people with kidney disease were required to shield themselves because of being classed as clinically vulnerable. Although the steering group actively inputted during this time, it was not to the degree that we initially envisaged when we began this work; however, we did what we were able to during such challenging circumstances. Thus, we consider this work to be co-designed with the elements of coproduction.

We acknowledge that MK&M may not meet the needs of those with lower levels of activation and/or health literacy. The findings from our mixed methods evaluation of MK&M will provide a wealth of information, including details regarding program usage, engagement, and adherence. Exploring patients’ and HCPs’ views and experiences of using MK&M will provide an in-depth understanding of its usability, functionality, and acceptability. The findings will inform the potential improvements and adaptations we could make to the program to ensure that it is more acceptable and accessible to disadvantaged groups. In addition, the program requires digital literacy and thus may exclude individuals who are not computer literate or do not have access to digital technology. More work is needed to improve digital literacy and ensure the provision of internet access. There is also scope for digital programs such as MK&M to address the health inequalities that exist in the CKD population, and further work is needed to explore how these programs could effectively reduce health inequalities in CKD.

This paper provides a detailed example of the application of IM in the development of a theory- and evidence-based digital self-management program for people living with CKD. We have been successful in developing a digital holistic CKD-specific self-management program that provides accessible, tailored, and interactive information and support to help people with CKD improve their awareness and understanding of their condition, health knowledge, and confidence in managing their condition. MK&M aims to provide ongoing self-management education, support, and guidance for people living with CKD to manage their condition and live full, productive lives. Results from the multicenter randomized controlled trial evaluating MK&M will provide evidence of the efficacy, effectiveness, and cost-effectiveness of the program. If MK&M is successful in increasing patient activation and subsequent self-management behaviors, we anticipate that it will also improve people’s QoL, physical function, and symptom burden while reducing the number of hospital admissions and saving costs to the NHS.