HES-SO University of Applied Sciences and Arts Western Switzerland, School of Health Sciences, Geneva, Switzerland.
University Hospital, Geneva, Switzerland.
Trials. 2019 Apr 29;20(1):243. doi: 10.1186/s13063-019-3333-4.
Venous leg ulcers are slow-healing wounds with a high recurrence rate of 70% and a 60% risk of becoming chronic. Signs and symptoms such as pain or exudate are not only a burden on those affected but also on the healthcare system and society in general. The estimated leg ulcer prevalence in the general population is 1%. Treatment costs for leg ulcers are estimated to be 3% of overall health expenditure. Current therapeutic approaches are multifaceted and include compression therapy, leg elevation, specific ankle-exercises and a protein diet. They require an interdisciplinary team of health care professionals. Approximately 70% of patients have a knowledge deficit with regards to therapeutic measures and have difficulties with adherence to treatment protocols. Therefore, it is of utmost importance that the treatment team provides effective patient education and support during the learning phase. However, there is little evidence and no published studies that describe and evaluate effective interdisciplinary educational interventions that target compliance/adherence to the treatment plan in patients with leg ulcers. We therefore propose to develop an evidence-based interprofessional educational intervention and evaluate its feasibility first in a pilot study and subsequently in a randomized controlled trial.
METHOD/DESIGN: First, the development of an evidence-based educational intervention in collaboration with an expert panel is proposed and second, a randomized controlled feasibility study in a wound-care outpatient clinic. Eligible patients (n = 20) with leg ulcers will be randomized to receive either interdisciplinary education and usual care or only usual care, for 12 weeks. Data will be analyzed using SPSS version 25. Univariate and bivariate analysis will be conducted according to the data level and distribution of the data.
We will first develop an evidenced-based educational intervention and second, we will examine the feasibility of implementing this educational intervention in a realistic care context in patients with leg ulcers. The results will inform the final design of a subsequent randomized controlled trial, which will examine the effectiveness of the educational intervention. An intervention that enhances patient adherence to therapy would be beneficial to individual patients and to society as a whole.
ClinicalTrials.gov, NCT03454698 . Registered on 6 March 2018.
静脉性腿部溃疡是一种愈合缓慢的伤口，其复发率高达 70%，且有 60%的风险发展成慢性溃疡。疼痛或渗出等症状不仅给患者带来负担，也给医疗保健系统和整个社会带来负担。据估计，普通人群中腿部溃疡的患病率为 1%。腿部溃疡的治疗费用估计占总医疗支出的 3%。目前的治疗方法是多方面的，包括压迫疗法、腿部抬高、特定的踝关节运动和高蛋白饮食。这些方法需要一个跨学科的医疗团队。大约 70%的患者在治疗措施方面存在知识缺陷，并且难以遵守治疗方案。因此，治疗团队在学习阶段为患者提供有效的教育和支持至关重要。然而，目前几乎没有证据和已发表的研究描述和评估针对腿部溃疡患者治疗计划依从性的有效跨学科教育干预措施。因此，我们建议制定一项基于证据的跨专业教育干预措施，并首先在试点研究中评估其可行性，然后在随机对照试验中评估其可行性。
方法/设计：首先，我们提议与专家小组合作制定一项基于证据的教育干预措施，其次，在伤口护理门诊进行一项随机对照可行性研究。符合条件的腿部溃疡患者（n=20）将随机分为接受跨学科教育和常规护理或仅接受常规护理，为期 12 周。数据将使用 SPSS 版本 25 进行分析。根据数据水平和数据分布，将进行单变量和双变量分析。
我们将首先制定一项基于证据的教育干预措施，其次，我们将在腿部溃疡患者的现实护理环境中检验实施这种教育干预的可行性。研究结果将为随后的随机对照试验的最终设计提供信息，该试验将检验教育干预的有效性。提高患者对治疗的依从性的干预措施将使个体患者和整个社会受益。
ClinicalTrials.gov，NCT03454698。于 2018 年 3 月 6 日注册。
