Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 16, 2025
Date Accepted: Jan 30, 2026
The effect of an educational intervention on the knowledge and the self-care skills of adult patients with venous leg ulcer: protocol of a randomized controlled trial
ABSTRACT
Background:
Venous ulcers have a prevalence of 1% in Western countries, with a tendency to become chronic and to 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 their 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.
Objective:
The objective of this study is to assess the superiority of an educational intervention delivered via video compared to an informative pamphlet on the knowledge of venous leg ulcers and the patient's self-care skills of nursing outpatient clinics.
Methods:
A total of 144 patients with venous leg ulcers who attend the nursing outpatient clinics will be recruited to participate in this randomized controlled trial. Individuals with cognitive impairment, an ankle-brachial index (ABI) of less than 0.90, or arterial insufficiency and arterial ulcers or of mixed origin will be excluded from the study. The intervention comprises four 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 and at 1-, 3- and 6-months post-enrolment, and at 12-months via telephone follow-up. The primary outcomes are the patient's level of knowledge and their ability to self-care. The secondary outcomes are the patient's 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.
Results:
All results, including clinical and imaging data, will be reported upon trial completion and publication.
Conclusions:
A video-based educational intervention may prove 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. Clinical Trial: Protocol registration number: NCT07031180, available at the link: Study Details | Educational Interventions in Venous Leg Ulcer | ClinicalTrials.gov Registration date 02/07/2026
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