Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients with Diabetes in Ethiopia: Protocol for a Randomized Controlled Trial

INTRODUCTION: Diabetes mellitus is a rapidly growing global public health problem; the number of adults with diabetes is expected to increase from 424.9 million in 2017 to 628.6 million in 2045. Approximately 80% of diabetic patients live in low- and middle-income countries where access to care may be limited. For example, in Ethiopia, diabetes care is often rudimentary, and formal, structured diabetes education is almost non-existent. One potential solution to the lack of diabetes management education for patients could be virtual simulation-based diabetes education incorporating the contextual realities of patients in Ethiopia. Despite its great potential to improve glycemic control, delay diabetes-related complications and reduce mortality associated with diabetes, the feasibility of virtual simulation-based diabetes self-management education has not been studied in low- and middle-income settings. OBJECTIVE: The purpose of the current study is to evaluate the feasibility of a virtual simulation-based Diabetes Foot Care Education (DFCE) program among adult patients with diabetes in Ethiopia. METHODS: A randomized controlled feasibility study including participants from University of Gondar Referral Hospital (UoGRH) will be conducted. A sample of 40 participants will be recruited, of which 20 participants will receive the virtual simulation-based education program, and the other 20 participants will continue with their usual diabetes care. After the education program, a questionnaire and structured interview will be used to explore the feasibility (acceptability, practicality) and the potential impact of virtual simulation-based DFCE intervention in patients with diabetes. Data will be analyzed using SPSS version 25 using descriptive statistics, independent t-tests, paired sample t-test, and factorial ANOVA at significance levels of less than 0.05. DISCUSSION: Our study seeks to understand the perceived usefullness and usability of virtual simulation-based diabetes foot care education on behavioural (diabetes foot-care knowledge, foot self-care practices, and foot self-care efficacy). Furthermore, the study will provide insight to assist in the development of technologically assisted and contextually designed DFCE programs. TRIAL REGISTRATION NUMBER: NCT04841291 (ClinicalTrials.gov Identifier).