{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T19:08:14Z","timestamp":1782846494612,"version":"3.54.5"},"reference-count":28,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Venous ulcers have a prevalence of 1% in Western countries, with a tendency to become chronic and recur frequently. The lengthy periods of healing required for the treatment of these lesions result in increased costs. It is possible that patient education may enhance patients\u2019 understanding of their health condition, which could potentially lead to a reduction in recurrence rates. Nevertheless, it is uncertain whether this constitutes the optimal educational strategy.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n The objective of this study is to assess the superiority of an educational intervention delivered via video compared to an informative brochure in outpatient nursing clinics, focusing on patients\u2019 knowledge of venous leg ulcers and their self-care skills.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n A total of 144 patients with venous leg ulcers who attend the outpatient nursing clinics will be recruited to participate in this randomized controlled trial. Individuals with cognitive impairment, an ankle-brachial index of less than 0.90, arterial insufficiency, and arterial ulcers or ulcers of mixed origin will be excluded from the study. The intervention comprises 4 short educational videos specifically created for this study, in which patients will be provided with information on disease knowledge, medication management, compression therapy, and the importance of adequate nutrition and physical activity. The control group will be provided with the standard education offered at the outpatient clinics participating in the study, which will be disseminated through an information leaflet. Patient assessments will be performed with standardized, validated tools at baseline; at 1, 3, and 6 months postenrollment; and at 12 months via telephone follow-up. The primary outcomes are the patient\u2019s level of knowledge and their ability to self-care. The secondary outcomes are the patient\u2019s level of well-being, the success rate of the treatment, and the recurrence rates. A preliminary feasibility study was conducted to methodologically refine the protocol.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n A feasibility study was conducted to refine study procedures and data collection tools, confirming the acceptability of the questionnaires and the feasibility of digital data collection. The randomized controlled trial was funded in June 2025. It is currently pending ethics approval, and it is expected to start recruitment in spring 2026. Results from the main trial are expected to be available by the end of 2027.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n A video-based educational intervention may prove to be an effective, readily accessible, and replicable method of patient education. The findings of this study will inform the most effective method of patient education for this population, ensuring the delivery of high-quality care and enhancing the quality of services.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/84211","type":"journal-article","created":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T15:40:06Z","timestamp":1769787606000},"page":"e84211-e84211","source":"Crossref","is-referenced-by-count":0,"title":["The Effect of an Educational Intervention on the Knowledge and Self-Care Skills of Adult Patients With Venous Leg Ulcers: Protocol for a Randomized Controlled 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Lo strumento di autoefficacia veluset per i pazienti con ulcera venosa delle gambe: adattamento culturale italiano e validazione psicometrica utilizzando un approccio bayesiano [Article in Italian]. University of Padua. 2021. 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