Abstract
BackgroundEnd-stage kidney disease is a life-changing illness. Many patients require haemodialysis, a treatment that impacts profoundly on quality of life and mental health. Arts-based interventions have been used in other healthcare settings to improve mental health and quality of life; therefore, they may help address the impact of haemodialysis by improving these outcomes. However, there is a lack of evidence assessing their effectiveness in this population and few randomised controlled trials (RCTs) evaluating the effectiveness of complex arts-based interventions.MethodsThe aims of this study are to establish the feasibility of a cluster RCT of an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis through a cluster randomised pilot study, explore the acceptability of the intervention with a process evaluation and explore the feasibility of an economic evaluation. The study will have three phases. The first phase consists of a cluster randomised pilot study to establish recruitment, participation and retention rates. This will involve the recruitment of 30 participants who will be randomly allocated through cluster randomisation according to shift pattern to experimental and control group. The second phase will be a qualitative process evaluation to establish the acceptability of the intervention within a clinical setting. This will involve semi-structured interviews with 13 patients and three focus groups with healthcare professionals. The third phase will be a feasibility economic evaluation to establish the best methods for data collection within a future cluster RCT.DiscussionArts-based interventions have been shown to improve quality of life in healthcare settings, but there is a lack of evidence evaluating arts-based interventions for patients receiving haemodialysis. This study aims to assess the feasibility of a future cluster RCT assessing the impact of an arts-based intervention on the wellbeing and mental health of patients receiving haemodialysis and identify the key factors leading to successful implementation. The hope is this study will inform a trial that can influence future healthcare policy by providing robust evidence for arts-based interventions within the haemodialysis setting.Trial registrationThe trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.
Highlights
IntroductionA treatment that impacts profoundly on quality of life and mental health
End-stage kidney disease is a life-changing illness
Lower health-related quality of life (HRQoL) is associated with increased morbidity and mortality in patients on haemodialysis [4]
Summary
A treatment that impacts profoundly on quality of life and mental health. Arts-based interventions have been used in other healthcare settings to improve mental health and quality of life; they may help address the impact of haemodialysis by improving these outcomes. End-stage kidney disease is the final stage of chronic kidney disease It is defined by an estimated glomerular filtration rate of < 15 ml/min/1.73 m2 [1]. Patients with end-stage kidney disease are poly-symptomatic and experience difficult symptoms including fatigue, pruritus, pain, nausea, sexual dysfunction and muscle weakness, which can profoundly impact quality of life (QoL) [2]. The main treatment modalities for end-stage kidney disease are renal replacement therapies, such as haemodialysis. Patients receiving haemodialysis have lower health-related quality of life (HRQoL) than the general population [3]. Patients receiving haemodialysis have higher rates of anxiety and depression, with approximately 20–50% of the patient population experiencing depression and/or anxiety [5,6,7,8,9]
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