The Effect of an Educational Intervention in Patient's Knowledge and Self-care Skills in Adult Patients With Venous Leg Ulcer in Outpatient Clinic of "Azienda ULSS 6 Euganea": a Two-arm, Single Centre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- The level of patient's knowledge
研究概览
简要总结
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.
详细描述
Background:
Venous Leg Ulcers (VLU) are skin lesions occurring in the lower limbs stem from increased venous pressure, resulting in vessel dilation and fluid stagnation in the leg's lower regions. This condition is a complication of chronic venous insufficiency, damaging vessel walls and surrounding tissues. In Western countries, about 3 per cent of the population over 80 years old are affected.
In Italy, the prevalence of this disease is constantly increasing among adults, particularly the elderly, who often have concomitant diseases.
In clinical settings, treating VLU commonly encounters prolonged healing periods and recurrent occurrences, leading to escalated treatment expenses and patient discomfort. Patients report pain, sleep disturbances, wound smell, impaired mobility, altered body image, decreased vitality and disappointment with treatment leading to a physical, psychological, and social distress, markedly diminishing their perceived quality of life.
Due to the chronicity and prevalence of these ulcers, patients or their caregivers are often involved in VLU management and self-care. The last includes maintaining health, monitoring, and managing one's health condition. Maintenance is the phase in which the patient prevents injury or recurrence by acting on the reduction of risk factors, monitoring is the process of observing signs and symptoms, and finally management includes how the patient responds to the eventual signs and symptoms . It is known as a barrier to self-management of VLU to not receive adequate health information, this prevents the patient or family member to maintain health, monitor signs and symptoms and manage the injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years;
- •with venous leg ulcer;
- •who understand Italian language;
- •who is able to read and understand the questions;
- •who attending to the nursing clinics involved in the study;
- •who have given consent to participate in the study;
- •who use a smart device with an internet connection or with caregiver able to provide the smart device as video player.
排除标准
- •with cognitive impairment;
- •who have an ankle-arm index/Winsor's index (ABI) less than 0.
- •/ with arterial insufficiency
- •patients with arterial or mixed-origin ulcers
结局指标
主要结局
The level of patient's knowledge
时间窗: 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
时间窗: 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.
次要结局
- VLU recurrence(12 months after enrolment)
- healing time(From enrollment to the end of treatment at 6 months)
- The well-being(From enrollment to the end of treatment at 6 months)
- VLU recurrence(12 months after enrolment)
- healing time(From enrollment to the end of treatment at 6 months)