Implementing an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis: a feasibility study protocol.

BACKGROUND

End-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.

METHODS

The 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.

DISCUSSION

Arts-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 REGISTRATION

The trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.

Déclaration de conflit d'intérêts

The author CC is a current PhD student at Queen’s University Belfast in Northern Ireland and will be undertaking this study as their PhD project, while HN, JR and IW are members of their supervisory team. Consequently the recruitment, implementation of the intervention, data collection for the cluster randomised pilot study, economic evaluation and process evaluation, and analysis of collected data, will all be completed by CC. Ideally these roles would be performed by different people or research teams to prevent introduction of bias, such as the halo effect, but the constraints of a PhD project do not allow this.This study has obtained ethical approval from the Office of Research Ethics Committees Northern Ireland (Ref: 18/NI/0091). An informed consent form will be signed by patients participating in the cluster randomised pilot study and parallel feasibility economic evaluation. A separate consent form will also be signed by patients and healthcare staff who participate in the parallel process evaluation.Not applicableThe authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.