Clinical Trial

Effectiveness of a Digital Health Education on Self-Foot Care and Quality of Life Among Patients With Diabetes

Unknown
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Record status
This record was last updated August 5, 2024 (before its estimated May 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
Diabetes is a significant global health concern, affecting over half a billion people and leading to severe complications like diabetic foot ulcers (DFUs). The increasing incidence of DFUs highlights the need for ongoing research and effective prevention strategies. A major challenge in managing DFUs is the inadequate preparation of healthcare professionals (HCPs) in delivering comprehensive diabetes self-management education (DSME). Enhancing the education and training of HCPs is essential to improve diabetes management and reduce DFUs. Studies show that patients' knowledge and self-care practices vary widely, with common foot-care activities including washing, drying, applying moisturizer, and routine nail care. Improving these self-care practices is crucial for early recognition and management of DFUs to reduce the risk of amputations. Health promotion models such as the Self-Efficacy Theory and Health Belief Model have shown promise in informing foot care interventions, but further research is needed to determine the most effective strategies. Previous research has several limitations, including selection bias, lack of consensus on outcome measures, and moderate risk of bias in some studies. The proposed study will use an experimental design with a nonequivalent control group to assess the effectiveness of DSME in reducing non-ulcerated diabetic foot incidents. Data will be collected using the Diabetes Self-Care Activities Foot Care Questionnaire and analyzed with statistical tests. Ethical guidelines will be strictly followed, ensuring participant confidentiality and voluntary participation. Overall, this research aims to address gaps in diabetes education and promote behavioral changes to improve diabetes care and reduce DFUs. Continuous training and education for HCPs are vital for enhancing their competence in managing DFUs and improving patient outcomes.
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06538168
Lead Sponsor Universiti Putra Malaysia
Collaborators: University of Lahore
Conditions Diabetic Foot Ulcer
Enrollment 2,430 participants
Start Date 2024-07-30
Primary Completion 2025-05-15 (estimated)
Study Completion 2025-06-25 (estimated)
Updated on ClinicalTrials.gov 2024-08-05