Educational Interventions in Venous Leg Ulcer

Condition(s) studied

Investigational drug(s) / intervention(s)

educational video: The experimental educational intervention will consist of professional video recordings that will cover the following topics: 1. Disease knowledge (VLU) 2. Medication management 3. The importance of compression therapy 4. Diet and physical activity The video recordings' contents will result from a review of the literature and guidelines, which will be later reviewed by a panel of experts in VLU. The video will be recorded by experienced video-maker and by a group of volunteers who will be the actors.

educational pamphlet (standard educational intervention): The educational brochure is an educational intervention already in use at the setting involved in the study.

Study summary

Background: Venous ulcers are skin lesions caused by impaired blood circulation. In Western countries, about 1% of the population is affected, and approximately 3% those over 80 years old. Venous leg ulcers tend to become chronic; a lesion is defined as chronic when it does not progress towards spontaneous healing. The treatment of these lesions inevitably involves long healing times, which results in increased healthcare costs. Moreover, venous leg ulcers have recurrence rates ranging from 18% to 28%. For this reason, it is important to support patients affected by or at risk of venous ulcers during their healing process or for prevention.

Objectives: The primary objective of the study is to assess the superiority of the educational interventions to the standard therapeutic education, in improving the patient's/caregiver's self-efficacy, after 4 weeks, 3, 6 and 12 months from the educational intervention begin. The secondary objectives are to clinically assess the impact of the educational intervention in decreasing healing time and recurrence rates and in patients' well-being after 12 months of follow-up. Additionally, the Well-being of Wounds Inventory (WOW-I) questionnaire will be validated in its Italian version.

Methods: the study is a two arm moncentric randomized-controlled trial. The participants will be randomly assigned into two groups. The control group will receive an educational intervention through a pamphlet, which represents the standard education received in the outpatient clinics involved in the study. The intervention group instead will receive an experimental educational intervention through video played specifically for this study. The socio-demografic, health and ulcer related factors will be collected and the questionnaires: venous leg ulcer knowledge (VLUK), Venous Leg Ulcer Self-Efficacy Tool (VeLUSET) and Well-being Of Wounds Inventory (WOW I) will be administered to the patients during the outpatient clinic visit, before the treatment and after 4 weeks, 3 and 6 months after the intervention. The study also includes a telephonic follow up at 12 months from the start carried out to assess if the patient's venous ulcer has healed or recurred.

Eligibility

Primary outcome measure(s)

• The level of patient's knowledge — From enrollment to the end of treatment at 6 months
  A primary outcome of this study is the change of the level of patient's knowledge about him/her disease. This outcome will assess by the administration pre and post the educational intervention of the "Venous Leg Ulcer Knowledge (VLUK)" questionnaire in its Italian version, that comprises 15 multiple-choice questions. The tool has a minimum score of 0 and a maximum of 15 where higher scores mean a better knowledge about VLU.
• The level of patient's self-care ability — From enrollment to the end of treatment at 6 months
  A primary outcome of this study is the change of the level of patient's self-care ability in the management of him/her disease. This outcome will assess by the administration, pre and post the educational intervention, of the "Venous Leg Ulcer Self Efficacy Tool (VeLUSET)". The tool comprises 30 itemswith a score from zero to ten (minimum score 0, maximum score 300), higer scores indicate more elevated perception of self-care ability.

Trial sites (1)

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