School of Nursing and Midwifery, Queen's University Belfast, Belfast, Northern Ireland, UK.
School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.
BMC Nephrol. 2020 Nov 19;21(1):497. doi: 10.1186/s12882-020-02162-4.
Haemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysis.
A parallel convergent mixed-methods design was used, including a pilot cluster RCT and qualitative process evaluation. Phase 1 evaluated recruitment and retention rates through a pilot cluster RCT at a single haemodialysis unit in Northern Ireland. Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent. These participants were randomised to the intervention or control group according to their haemodialysis shift. The intervention involved six one-hour, one-to-one facilitated arts sessions during haemodialysis. Phase 2 explored intervention and trial acceptability through a qualitative process evaluation using semi-structured interviews based on the RE-AIM framework. Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation.
Out of 122 outpatient haemodialysis patients, 94 were assessed as eligible for participation. Twenty-four participants were randomised, meaning 80% of the target sample size was recruited and the attrition rate at 3 months was 12.5% (n = 3). Participants viewed the arts as more accessible and enjoyable than anticipated following implementation. All participants who started the intervention (n = 11) completed the full six sessions. Qualitative benefits of the intervention suggest improvements in mental well-being. Patient choice and facilitation were important factors for successful implementation.
An arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible. The intervention may help improve mental-wellbeing in patients receiving haemodialysis, but this requires further investigation in a definitive trial.
The trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496 .
血液透析会对生活质量和心理健康产生负面影响。在其他环境中成功应用的以艺术为基础的干预措施可以改善健康和幸福感，有助于解决血液透析的影响。本研究旨在评估对接受血液透析的患者进行以艺术为基础的干预措施的随机对照试验（RCT）的可行性和可接受性。
采用平行收敛混合方法设计，包括一项试点集群 RCT 和定性过程评估。第 1 阶段在北爱尔兰的一个单一血液透析单位进行了试点集群 RCT，评估了招募和保留率。参与者包括接受终末期肾病血液透析治疗、年龄在 18 岁以上且有能力同意的患者。这些参与者根据血液透析班次随机分配到干预组或对照组。干预措施包括在血液透析期间进行六次一对一的、由专业人员协助的一小时艺术课程。第 2 阶段通过基于 RE-AIM 框架的半结构化访谈，使用定性过程评估探索干预措施和试验的可接受性。参与者包括参加研究第 1 阶段的 13 名患者，其中实验组 9 名参与者，对照组 4 名参与者，以及实施期间在单位的 9 名医疗保健专业人员。
在 122 名门诊血液透析患者中，有 94 名被评估为符合参与条件。随机分配了 24 名参与者，这意味着达到了 80%的目标样本量，3 个月时的失访率为 12.5%（n=3）。参与者认为艺术比预期更容易获得和有趣。所有开始干预的参与者（n=11）都完成了全部六次课程。干预的定性益处表明，心理健康得到了改善。患者的选择和促进是成功实施的重要因素。
为接受血液透析的患者提供的以艺术为基础的干预措施对患者和医疗保健专业人员都是可接受的，并且进行确证性试验是可行的。该干预措施可能有助于改善接受血液透析的患者的心理健康，但这需要在确证性试验中进一步研究。
该试验于 2018 年 8 月 14 日在 clinicaltrials.gov 上进行了前瞻性注册，注册号为 NCT03629496。
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