Woodward Sue, Graham Tanya, Sooriah Sangeeta, Beeckman Dimitri, Chatterton Chris, Fader Mandy, Fiorentino Francesca, Fitzpatrick Joanne M, Harris Ruth, Kottner Jan, Norton Christine, Worsley Peter
Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.
Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK
BMJ Open. 2024 Dec 23;14(12):e092338. doi: 10.1136/bmjopen-2024-092338.
Incontinence is commonly experienced by adults who receive care support in a residential facility or in their own home. These individuals are at risk of developing incontinence-associated dermatitis (IAD), which is caused by prolonged and repeated exposure of the skin to urine or faeces. An IAD manual was developed providing an evidence-based clinical algorithm and an e-learning training programme for the prevention and treatment of IAD. The aim of the study is to establish the feasibility of conducting a definitive trial to examine the clinical and cost-effectiveness of the IAD manual. The objectives are to assess recruitment and attrition rates, acceptability of the IAD manual and intervention fidelity.
A feasibility cluster randomised controlled trial will be conducted in residential nursing homes and in the homes of people receiving formal care support in London and Hampshire, England. A total of six clusters including n=248 participants who are incontinent of urine, or faeces will be included. At each intervention site, care staff will be trained to implement the IAD manual over a 6-month period. Quantitative outcomes include IAD incidence and severity, IAD-related pain, satisfaction with care and mental health. A qualitative evaluation of care staff and care receivers' experiences of participation will be conducted. Rates and proportions of each feasibility outcome will be described informing the sample size estimation for a definitive cluster randomised controlled trial. A thematic analysis of the qualitative data will be guided by a logic model detailing potential factors impacting on both the study methodology and adoption of the IAD manual into routine care.
The study received the approval of the Queens Square Ethics Committee Health Research Authority 23/LO/036, (Project ID 296167). Results will be disseminated through peer-reviewed open-access journals and international conferences TRIAL REGISTRATION NUMBER: ISRCTN70866724.
在养老院或自己家中接受护理支持的成年人常出现失禁问题。这些人有发生失禁相关性皮炎(IAD)的风险,这是由于皮肤长期反复接触尿液或粪便引起的。已制定了一份IAD手册,提供基于证据的临床算法以及用于IAD预防和治疗的电子学习培训课程。本研究的目的是确定进行一项确定性试验以检验IAD手册的临床和成本效益的可行性。目标是评估招募率和损耗率、IAD手册的可接受性以及干预保真度。
将在英格兰伦敦和汉普郡的养老院以及接受正式护理支持的人员家中进行一项可行性整群随机对照试验。总共将纳入六个整群,包括n = 248名尿失禁或大便失禁的参与者。在每个干预地点,护理人员将接受培训,在6个月的时间内实施IAD手册。定量结果包括IAD的发生率和严重程度、与IAD相关的疼痛、护理满意度和心理健康状况。将对护理人员和护理接受者的参与体验进行定性评估。将描述每个可行性结果的发生率和比例,为确定性整群随机对照试验的样本量估计提供依据。将以一个逻辑模型为指导,对定性数据进行主题分析,该模型详细说明了影响研究方法以及将IAD手册纳入常规护理的潜在因素。
本研究获得了女王广场伦理委员会健康研究管理局23/LO/036(项目ID 296167)的批准。研究结果将通过同行评审的开放获取期刊和国际会议进行传播。试验注册号:ISRCTN70866724。