This randomized, investigator-blinded, 2-armed, pilot study was conducted on patients with diabetes who visited Dasman Diabetes Institute (Kuwait City, Kuwait) clinics from January 2019 to May 2024. Each participant was fully informed about the study prior to giving their written informed consent.

Participants had to meet the following inclusion criteria: (1) adult patients (≥18 years of age) with type 2 diabetes or adults with type 1 diabetes for ≥5 years, (2) be of medium or high DFU risk, defined as having at least 1 diabetic foot risk factor (loss of pain perception, peripheral vascular disease, foot deformity, history of DFU, or amputation), (3) able to understand study procedures and comply with them for the entire length of the study, and (4) must own a smartphone with internet access and agree to have the phone app uploaded for the duration of the study. People with chronic kidney disease, cognitive impairment, active psychiatric illness, inability to give written informed consent, hearing or visual impairment, or phone app inaccessibility for more than 4 weeks were excluded from the study.

The foot care knowledge questionnaire used in this study has been adapted from Pollock et al [31] and Rheeder et al [32]. The questionnaire covers 2 sections. The first section consisted of 7 questions with 3 options each: correct, incorrect, and don’t know. A correct answer was awarded 1 point, while incorrect or “don’t know” responses received 0 points. The second section consisted of 5 questions with multiple-choice options. A correct answer was awarded 1 point, while an incorrect answer received 0 points. The maximal total score is 12 points, with higher scores indicating a better understanding of foot care knowledge.

The foot care and diabetes self-care behaviors questionnaire has been adopted from the Summary of Diabetes Self-Care Activities (SDSCA). The SDSCA has been found to have both reliability and validity as a standard measure of diabetes self-management [33]. Furthermore, this test has been shown to be reliable and valid, giving consistent results when translated into Arabic in a sample size of 243 participants [34]. The SDSCA scale measures the frequency of each self-care activity in the last 7 days for 4 aspects related to diabetes routine: foot care (8 scaled questions), blood-glucose testing (2 scaled questions), medications adherence (2 scaled questions), and smoking habits (2 questions). For this analysis, the score of the scaled questions (from 0 to 7 d) was calculated as the average of responses within each section [33]. A higher total score indicates better foot self-care behavior.

Although this is a pilot study, a sample size of 98 with a 1:1 ratio between intervention and control group (49:49) was calculated using G*power software (version 3.9.1.2; Heinrich-Heine-Universität Düsseldorf). An a priori difference between 2 independent means tests was performed to find a significance interaction with a power of 80% and probability of type 1 error of 0.05. The effect from a study by Baba et al [35] was a significant mean change of 1.8 (SD 2.6) reduction in foot score (based on the presence and severity of 15 podiatry disorders; n=78) compared to a 0.1 (SD 2.6) reduction in the foot score after receiving interactive education (n=76) over 3 months (effect size=0.58).

Data analysis was performed using SPSS Statistics (version 29.0; IBM Corp). Descriptive statistics were represented as mean (SD) for continuous variables and as frequencies for categorical variables. The Shapiro-Wilk test was used to assess normality for each continuous variable to determine the appropriate use of parametric or nonparametric tests. Chi-square tests and independent 2-tailed t tests were conducted to test to examine baseline differences between the groups and to compare the frequency of new DFU cases between the study groups. The Wilcoxon signed-rank test was used when the assumption of normality was violated.

Both intention-to-treat (ITT) and per-protocol (PP) analyses were conducted. The ITT analysis included all randomized participants with the available outcome data, regardless of adherence or dropout status. A linear mixed model was used to evaluate group, time, and group×time interaction effects on the outcome measures: foot care knowledge scores, foot care, blood-glucose testing, and medication adherence behaviors.

Post hoc pairwise comparisons were conducted using the matched pair 2-tailed Student t test or Wilcoxon signed-rank test, with Bonferroni adjustment applied for multiple comparisons. Bivariate Pearson or Spearman correlation analyses were performed to evaluate the strength and direction of relationships between the change in foot care knowledge scores and foot self-care behavior: scores and the number of follow-up visits. Changes in scores were calculated as 12 month values − baseline values. P values <.05 were considered statistically significant.

Ethical approval was granted by the Dasman Diabetes Institute Ethical Review Committee (RA HM‑2018‑044). The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines and was registered at ClinicalTrials.gov (NCT03934944). The trial was conducted and reported in accordance with the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) 2011 guidelines (Checklist 1).

Written informed consent was obtained from all participants prior to enrollment. Participant privacy and confidentiality were strictly maintained throughout the study: all data were deidentified and stored on secure, password-protected servers accessible only to authorized research personnel, and no personally identifiable information was included in the analysis or reported in the manuscript. Participants did not receive financial compensation for their participation.

This pilot study investigated the effectiveness of a multimedia educational approach in improving foot care knowledge and behavior among individuals with diabetes over a 12-month period. Overall, this study found that there was no long-term benefit to using multimedia educational tools in addition to standard usual podiatry care to improve participants’ knowledge and behavior. However, post hoc comparisons showed that while both usual care and multimedia educational approaches enhanced the foot care behaviors of participants, the usual care settings resulted in a decline in their foot care knowledge, whereas the multimedia educational settings maintained it. The effect on glycemic control, however, was marginal and not clinically relevant (nonsignificant reduction in HbA_1c of only 0.52%). The consistency of results between the ITT and PP analyses supports the robustness of our findings and indicates that participant dropout did not substantially bias the outcomes. This consistency increases confidence that the observed effects are likely to be representative of real-world settings.

Delivering the appropriate foot self-care education is a crucial strategy for reducing the risk of DFUs in people with diabetes [36]. Though there is currently no consensus regarding the optimal education method on diabetic foot care among health care professionals [37]. In light of technological advancements, several interventional studies using smartphone apps and media aids were conducted to educate patients about foot self-care [38]. But their effectiveness remains unclear. To the best of our knowledge, this is the first study that examined the long-term (12 mo) effects of multimedia educational tools on diabetic foot care including both audio-visual presentation and smartphone app. In support of our findings, a short-term (3 mo) RCT on 120 individuals with diabetes found that an audio-visual educational presentation, supplementary to standard diabetic care and regular reinforcement of education in outpatient clinic, significantly enhanced knowledge scores by +1.17 (95% CI 0.7‐1.64, P value<.001) compared to those receiving standard care alone (+0.1, 95% CI −0.3 to 0.5, P=.62), whereas the practice scores were significantly improved in both groups (intervention: +1.6, 95% CI 1.09‐2.11, P<.001; control: +0.48, 95% CI 0.16‐0.8, P=.004) [39]. A 3-week educational program involving presentation slides, booklets, and group discussions significantly improved knowledge (intervention: mean 8.08, SD 0.88 vs control: mean 7.17, SD 1.91; P=.02) and behavior scores (intervention: mean 19.32, SD 6.48 vs control: mean 18.96, SD 7.36; P=.0001) compared to usual care [40].

Contrary to our findings regarding the use of a smartphone app, a recent RCT study involving 88 participants found that m-DAKBAS, an educational mobile diabetic foot care app that involved information, prevention, and management interfaces, significantly improved knowledge scores over a 6-month period (intervention: mean 16.83, SD 1.56 vs control: mean 15.05, SD 2.17; P=.0001), with no significant differences in behavior scores (intervention: mean 62.59, SD 7.76 vs control: mean 59.45, SD 10.53; P=.23) [41]. Furthermore, a 2-month use of the MobileDiabetes self-care app, which allowed patients to improve their self-care practices with flexibility in timing, location, and choices, has been shown to increase both patients’ self-care knowledge and behavior by 17% and 22%, respectively [42]. In a 1-month RCT, an animation-supported app (Mobile Diabetic Foot Care Education; M-DFCE) that delivered 2 push alerts per week and included a cartoon animation providing basic education on daily foot care to prevent foot wounds was evaluated [43]. The experimental group outperformed the control group in terms of foot care behavior (mean difference: 11.28, SD 10.47 for intervention vs 0.6, SD 24.85 for control; P =.01) and knowledge (mean difference: 0.87, SD 1.21 for intervention vs 0.01, SD 1.25 for control; P=.002) when compared to baseline [43]. According to a recent systematic review, for patients with diabetes, using a mobile health app enhanced their awareness of the disease and their capacity for self-care in studies of durations of less than 6 months [44]. A study involving 58 patients with uncontrolled diabetes found that integrating self-management, through peer-supporting video, a quiz game, and a feedback system, with the Diabetes Care App for 5 weeks, improved foot care behavior significantly (P<.01) when compared to usual care [45]. Similar improvements in foot care practices were observed on patients with type 2 diabetes after 1 month [46] and 3 months [47] of using self-management integration with smartphone apps. Furthermore, the use of smartphone apps and alerts interventions has been associated with improved glycemic control [48], which is contrary to our findings. We found a minor and comparable decrease in HbA_1c among the 2 groups, which might be reflected by their scores of the blood glucose-testing and medication adherence. While multimedia education on foot self-care is essential for improving the knowledge and behavior of individuals at a moderate-to-high risk of DFUs, it did not have a significant impact on glycemic control or long-term behavior changes.

In this study, there was no discernible difference in the overall incidence of DFU across the groups, although the overall incidence and thus the study power were low. This may suggest that the use of multimedia aids in foot self-care does not offer additional benefits above the usual care education. In agreement with our findings, a systematic review of 6 RCTs found insufficient evidence for the benefit of an integrated care approach, which involved combining multiple DFU prevention strategies at different levels of care (including the patient, health care provider, and health care structure), indicating the need for more high-quality studies [22]. Another systematic review of 11 RCTs, on the other hand, showed that educational technologies were protective against the incidence of lower limb amputations (relative risk=0.53, 95% CI 0.31‐0.90; P=.02) and DFU (relative risk=0.40, 95% CI 0.18‐0.90; P=.03), despite the lack of evidence of certainty assessment [49]. Other studies suggested that a more focused and intensive educational approach should be adopted to reduce the incidence of DFU. An RCT on people with type 2 diabetes found that 2-hour focused education sessions, including practical exercises on foot care behaviors, were effective in preventing the incidence of DFU during 6-month follow-ups compared to the control group (incidence of DFU=0% vs 10%; P=.01) [50]. Similarly, a quasi-experimental study found that combining educational sessions with foot assessment and care reduced the recurrence rate of DFU to 13.3% compared to 33.3% in the control group [51]. Intensive education approaches that included training and customized footwear have been shown to reduce the incidence rate of new DFU compared to usual care by 18% and 31%, respectively [52]. The results from a systematic review and meta-analysis of RCTs demonstrated that, in comparison to the control group, an intensive educational approach—a 45- to 1-hour education session reinforced by written instructions—significantly decreased the risk of DFU incidence (relative risk 0.37, 95% CI 0.14-1.01; P=.05) [53]. Nonetheless, the study showed that there was a substantial degree of variability in the studies, with 91% heterogeneity [53]. Thus, multimedia aids may not offer additional benefits beyond usual care in reducing the incidence of DFU among individuals at a moderate-high risk of DFUs, suggesting the need for more targeted educational approaches. Although our study did not find a significant effect on self-care behavior, this should not be interpreted as evidence against the long-term effectiveness of all media-based tools, which may require extended follow-ups, greater interactivity, or more tailored content to achieve meaningful and sustained behavioral change. In addition, future studies should consider evaluating the effectiveness of media-based educational tools in lower-risk populations, where such interventions may have a greater impact on preventive behaviors and outcomes.

The strength of this pilot study is the long-term duration of the intervention at 12 months. However, a major limitation of this study is the unexpected COVID-19 global pandemic and associated government restrictions, which significantly impacted study conduct and led to lower enrollment and higher dropout rates than expected. This was potentially because, as a high-risk group for COVID-19, participants were reluctant to increase their contact with others unnecessarily. Although there was a higher dropout among participants with a high risk, particularly in the control group, our ITT analysis yielded results consistent with the PP analysis, suggesting that differential attrition did not substantially bias the study findings. The small sample size limits the generalizability of our findings, and thus, future studies with larger and more diverse populations are needed to validate these results and better evaluate the effectiveness of app-based interventions. Another limitation is that the MyU app lacked interactive features, which may have reduced its appeal—particularly among older participants [54,55]—although this was not formally assessed through usability testing or structured feedback during the study.

In conclusion, the study findings revealed that a multimedia education approach alone to improve foot self-care knowledge and behavior was unfeasible and not engaging for long-term use in people at a moderate-high DFU risk. However, the reinforcement of educational material in the follow-up podiatry visit might be effective in achieving persistent changes in foot care behavior of this patient group. Given the scope of this study, further confirmative RCT studies, with a larger sample size, are needed.