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Developing and evaluating a mobile foot care application for persons with diabetes mellitus: a randomized pilot study [with consumer summary]
Kilic M, Karadag A
Wound Management & Prevention 2020 Oct;66(10):29-40
clinical trial
4/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

Ulceration of the foot is a major complication of diabetes mellitus, and optimal self-care may help prevent its development. Research suggests that mobile applications (apps) may affect behavioral change. OBJECTIVE: The purpose of this study was to develop the mobile diabetic foot personal care system (m-DAKBAS) and evaluate its effectiveness for patients with diabetes. METHOD: During phase 1, a mobile app that included communication features, remote patient monitoring, and information was developed and pilot-tested among 10 patients. The phase 2 study, conducted from June 2017 to April 2018, used a 2-group, pre-test/post-test design to evaluate the effect of the app on patients' knowledge, behavior, and self-efficacy scores when used for 6 months. Both the experimental (app) and control groups participated in 1 education session at the start of the study. RESULTS: Of 106 patients who enrolled, 88 completed the study (44 in the experimental group and 44 in the control group). Only 6 patients had received education about foot care previously. The average age of all participants was 51.63 years (SD 8.08). There were significantly more women in the experimental group than in the control group (65% versus 45.5%; p = 0.5). Each participant used the app for 24 weeks, and the data entry rate was 72.9%. Throughout the study, participants had 1977 data entries (blood glucose and foot observation) in total. Differences between pre- and post-intervention test scores were significantly higher for knowledge, behavior, and self-efficacy in both groups, but the difference was greater in the experimental group (p < 0.05). Only post-test knowledge scores were significantly higher in the experimental compared with the control group (p < 0.05). Compared to the start of the study, the proportion of participants with cracked/dry skin and inappropriate footwear was significantly lower in the experimental group but not in the control group. CONCLUSION: In this study, education and follow-up via the mobile app and verbal-only instruction increased the knowledge, behavior, and self-efficacy scores of patients in both groups. Post-study knowledge scores were significantly higher in the experimental group than in the control group. Patient education remains a crucial component of optimal care, and further development, refinement, and testing of mobile applications to improve self-efficacy and reduce the risk of diabetic foot are warranted.

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