According to the International Diabetes Federation, 537 million people worldwide (ie, 1 in 10) lived with diabetes in 2021, and this number is expected to rise to 783 million by 2045 [1]. The lifetime incidence of developing a diabetic foot ulcer (DFU) in adults living with diabetes ranges from 19% to 34% [2]. In a 2017 systematic review and meta-analysis, DFU's global prevalence among people with diabetes was estimated to be 6.3%, with Asia having a prevalence of 5.5% [3]. Diabetes-related lower extremity complications affected an estimated 131 million people (1.8% of the total global population) in 2016, with overall age-standardized rates for years lived with disability increasing by 15.9% between 1990 and 2016 [4]. Southern sub-Saharan Africa, South Asia, and Southeast Asia experienced the greatest growth during the period. Despite multiple clinical [5], economic [6,7] and policy [8,9] attempts to address DFU in Singapore, the country is still struggling to combat the rising prevalence of DFU-related complications with a reported 1500 DFU-related lower-limb amputations performed each year [10]. Furthermore, the estimated recurrence rate is 22.1% per person-year [11]. Hence, DFUs impose a significant clinical and economic burden on health care systems around the world as well as significant reductions in the quality of life for those affected [12].

Prevention initiatives, including lifelong patient education and continuous empowerment, are key strategies for successful foot care and management of diabetes, as recommended by evidence-based guidelines [13]. Whether delivered one-to-one or in small groups, diabetes foot health education is resource-intensive and costly—requiring the participation of doctors, nurses, podiatrists, diabetes educators, and allied health professionals. While valuable, foot care and diabetes education sessions lack immediacy, timeliness, access, and flexibility. In Singapore, 36% of patients with diabetes reported receiving no diabetes education [14] and over 51% spend less than a minute checking their feet [15]. Given the unmet need, financial and health workforce constraints, and being in line with modern approaches to education and self-management support, a digitally supported diabetes education mobile health (mHealth) apps using prevention and management of the DFU education program carries the potential to improve health care delivery and increase uptake, equity, and cost-effectiveness of health services related to DFU. Patient-facing technology such as mHealth apps can be blended with face-to-face care to augment the overall delivery of care and health services [16] and impact patients’ health outcomes [17].

The other agency that is heavily involved in the management of DFU is the carer. Informal carers are defined broadly as any family member, partner, or friend who provides support to a person having a chronic condition. Carers play a vital role particularly in assisting with wound care, monitoring changes, ensuring foot hygiene, managing medications, offering emotional support, advocating for medical care, and providing education [18]. Carer’s involvement improves patient outcomes, prevents complications, and enhances overall DFU care and well-being. For many people with chronic conditions, particularly the elderly, informal carers provide support and take responsibility for many of the care needs. Upskilling informal carers may result in better health outcomes [18]. Training equips them with skills to provide effective wound care, identify issues early, prevent complications, manage medications, offer emotional support [19] and promote timely access to health care. This improves the overall DFU management beyond the hospital walls, which may eventually result in reduction of hospitalizations, lowers costs of health care, and ensures collaborative, sustainable DFU management among patients, carers, and health care professionals.

Studies suggest that people living with diabetes show an interest in mHealth apps for preventing and monitoring DFUs [20]. There is a growing body of evidence supporting the potential of mHealth apps to enhance diabetes self-management performance [21]. A few studies have been conducted to assess or validate the potential of an mHealth app for diabetic foot care. Some of them focus on providing wound care trackers [22,23], others on empowering with knowledge on foot-ankle exercises [24], quick tips on foot care and first aid, reminders for medical check-ups, a contacts feature to save health providers’ contact information [25], text messaging [26], foot care essentials [27,28], foot care education in 6 animations [29] and tips for self-assessment [30]. Prior to a full trial, feasibility studies are routinely performed to determine whether a future study is feasible [31].

Some of the challenges identified in such interventions include maintaining patient engagement [25], tailoring content to the different stages of complexity of the disease, retaining and applying the knowledge acquired [32]. Thus, there is a need to explore the mechanisms by which evidence-based behavior change techniques and digital features can influence the uptake of digital diabetes and foot care education and ultimately improve diabetes health literacy and self-management behaviors. Even though the validation studies presented promising results, none of the mHealth apps for DFU comprise comprehensive in-depth education on all aspects of foot health, including prevention, inspection, and wound care while concurrently providing support for self-management with tracking features that focus both on feet health and general diabetes care. Additionally, no other tool addresses the need for a multilingual and adaptive solution that fits individual needs, such as the role (patient or caregiver), severity of the condition, and competency levels, concurrently reinforcing learning through notifications and spaced learning. Finally, there is a necessity to understand the user’s engagement and app effectiveness in detail using granular click-level data.

This is a “proof-of-concept” feasibility study to evaluate a foot health education app for people living with diabetes, Well Feet, among patients and carers. Prior to a full trial, feasibility studies are routinely performed to determine whether a future study is feasible [31].

This study is a nonrandomized, single-arm feasibility study with baseline, end point, and focus-group discussion design. An explanatory sequential mixed methods approach will be used to assess feasibility and usability of the mHealth app, Well Feet. Our study features a 1-month intervention period carefully designed to strike a balance between meaningful observation and participant convenience. This timeframe enables us to assess the feasibility of the intervention on our selected outcomes. All participants will receive Well Feet, and their feedback will be collected through quantitative and qualitative rating measures. Subsequently, focus group discussions will be conducted to provide valuable insights into their experiences. The reporting of this protocol follows CONSORT (Consolidated Standards of Reporting Trials) 2010 statement extension for feasibility studies [33]. This study has been registered at ClinicalTrials.gov (NCT05564728).

Since this is a feasibility study, a formal sample size calculation is not required [34]. Our target is to recruit a minimum of 30 participants (with a maximum of 40), evenly divided into groups: persons living with diabetes and carers of persons living diabetes, with 15 participants in each group (with a maximum of 20). This approach is based on a previous study that shows a feasibility study requires 30 or more participants to estimate a parameter [35]. An arbitrary sample size of 30 would provide 0.75 (75%) power to detect a medium effect size of 0.5. Alternatively, a sample size of 40 would provide even greater power at 0.87 (87%).

All data will be handled according to patient Nanyang Technological University data protection and privacy policy [45] as well as National Healthcare Group, Tan Tock Seng Hospital data protection and privacy policy [46] with all participants assigned a study ID to deidentify data and any personal information about participants will be stored separately from deidentified data. Data collected via digital survey platform, REDCap will be stored on secure servers at Center for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University. The data gathered through the app will be stored in a university-approved cloud server as a multiencrypted database with authorization granted for principal investigators and study team members to prevent unauthorized persons from accessing the data. All other physical forms will be stored in a locked filing cabinet in the clinical site and will be accessible only to the site-principal investigator and appointed research assistant. User’s interaction within the Well Feet app will be monitored to identify participants’ signaling their need for more extensive support.

This study was approved by the National Healthcare Group Domain Specific Review Board (2022/00614) and the Nanyang Technological University institutional review board (IRB-2023-157), ensuring that the welfare and rights of all participants is protected in this study. This study will be conducted in accordance to the Helsinki code of ethics ensuring that patients’ confidentiality, integrity, and vulnerability are kept throughout their participation. Informed consent will be collected to ensure participants are aware of this study’s procedure and their rights to withdraw from this study without the need to give any reason. Participants will be provided with contact information within the informed consent form should they have any concern regarding the conduct of the feasibility study.

This study’s findings will be published in an open access journal and via national and international conference presentations.

This study is designed with the aim to evaluate the feasibility of Well Feet, a mobile health app designed for people living with diabetes and at risk of DFU. This study will provide insights on Well Feet’s added values, potential benefits, and challenges of its use among patients and carers. Through a combination of quantitative evaluation using the validated MAUQ questionnaire and qualitative insight from focus group discussions, this study will provide a perspective on the feasibility of Well Feet particularly on how the app facilitates patients and carers engagement in diabetes foot health management. Additionally, analytics derived from Well Feet usage data will provide a clearer picture on user interaction with features of the app.

Studies ranging from early detection and prevention to self-monitoring apps collectively highlight the potential of mHealth in improving patient outcomes, and addressing challenges in diabetes care [48]. We are expecting that similar to other studies a difference in knowledge pretest and posttest knowledge score will be observed [49,50] and that the app will be perceived as valuable [22,24,25,27,28,51]. However, as the learning curriculum included in Well Feet app is much more comprehensive than in other solutions and encompasses multilevel tailoring mechanisms such as notifications for learning reinforcement and adaptive learning pathway for knowledge gaps identification, we are expecting that the foot care knowledge and behavior results will differ from other studies. The qualitative analysis will additionally help to identify specific behavioral changes among study participants going beyond observing frequency of foot checking [20].

Furthermore, in this study we are aiming at in app exploring usage patterns among the participants, especially those who experienced knowledge or behavior change. Ploderer et al [51] has observed 3 usage patterns when evaluating a wound care tracking app: continuous, temporary, and failing usage. In our study, it is expected that some barriers to usage identified by Ploderer et al [51] will overlap, especially the ones leading to temporary usage such as work commitments and health disruptions. As the sample of participants will vary across different risks of developing DFU and will include low and moderate risk patients, the frustration with lack of healing progress might not arise. The usage and learning analytics of click-level data should allow us to further describe exact app behaviors that constitute each group of users. Usage patterns will be juxtaposed with knowledge and behavior questionnaires’ results to further reveal engagement patterns and factors influencing the success of foot care education.

This study comes with a set of strengths and limitations. A structured approach described in this protocol will be used to assess the practicality and viability of a newly developed adaptive diabetes foot health education, Well Feet, before a full-scale development and deployment. The utilization of both quantitative and qualitative measures enhances the depth and breadth of insights gained from this evaluation. By performing a feasibility study, the research team will be able to identify technical, operational, and logistical challenges early in the process, thus potentially saving time and resources when a larger randomized controlled trial is conducted.

However, there are several limitations worth noting. The small cohort of study participants recruited from a single tertiary hospital limits the generalizability of findings. A follow-up multicenter randomized controlled trial is warranted to predict a proper intervention effect. Second, while only patients who owned mobile devices were recruited, no formal assessment of digital literacy was performed during the recruitment process. As smartphone ownership may not be an accurate indicator of proficiency in using basic phone features [52], patient’s engagement with Well Feet app may be impacted by limited digital literacy.

Patient-facing digital health technologies such as mHealth apps promise to support self-management of various health conditions, including diabetes and associated risk factors. Such feasibility research, especially when it encompasses user-centered design and evaluation, contributes to health care services transformation aimed at equitability, patient empowerment, and shared decision-making. Gaining growing attention from researchers [53] and patients [15], mHealth interventions pave the road for future health care where digital solutions, including health education, are seamlessly integrated into routine prevention and care. This feasibility study is a step in embracing technological innovations which aim to optimize advancing a DFU prevention and management and care delivery.