Educational Interventions in Venous Leg Ulcer
ConditionVenous Leg Ulcers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Padova
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
older than 18 years;
with venous leg ulcer;
who understand Italian language;
who is able to read and understand the questions;
Disqualifiers
with cognitive impairment;
who have an ankle-arm index/Winsor's index (ABI) less than 0.90. / with arterial insufficiency
patients with arterial or mixed-origin ulcers
Trial design
Design model
Parallel
Treatments tested in this trial
educational video
Other interventionThe 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)
Other interventionThe educational brochure is an educational intervention already in use at the setting involved in the study.
Treatment groups
142 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The level of patient's knowledge
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.
Time frame
From enrollment to the end of treatment at 6 months2
The level of patient's self-care ability
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.
Time frame
From enrollment to the end of treatment at 6 monthsSecondary outcomes
1
VLU recurrence
A secondary outcome is the number of recurrences of VLU in the participants at 12 months.
Time frame
12 months after enrolment2
healing time
A secondary outcome is the number of patients cured during follow-up. This will be assessed using the PUSH 3.0 instrument score.
Time frame
From enrollment to the end of treatment at 6 months3
The well-being
A secondary outcome is the change of well-being in patients with VLU. This outcome will assess by the administration pre and post the educational intervention of the "Well-being Of Wounds Inventory questionnaire (WOW I)", wich include 19 items with a five points likert scale, higer scores indicate better well-being.
Time frame
From enrollment to the end of treatment at 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Padova
Lead sponsor
Azienda Ulss 6 Euganea
Collaborator
Source ClinicalTrials.gov
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