The NightLife study - the clinical and cost-effectiveness of thrice-weekly, extended, in-centre nocturnal haemodialysis versus daytime haemodialysis using a mixed methods approach: study protocol for a randomised controlled trial

Katherine L Hull*, Kate Bramham, Cassandra L Brookes, Victoria Cluley, Carmel Conefrey, Nicola J. Cooper, Helen Eborall, James Fotheringham, Matthew P M Graham-Brown, Laura J Gray, Patrick B. Mark, Sandip Mitra, Gavin J Murphy, Niamh Quann, Leila Rooshenas, Madeleine Warren, James O Burton

*Corresponding author for this work

Research output: Contribution to journalProtocol

Abstract

BACKGROUND: In-centre nocturnal haemodialysis (INHD) offers extended-hours haemodialysis, 6 to 8 h thrice-weekly overnight, with the support of dialysis specialist nurses. There is increasing observational data demonstrating potential benefits of INHD on health-related quality of life (HRQoL). There is a lack of randomised controlled trial (RCT) data to confirm these benefits and assess safety.

METHODS: The NightLife study is a pragmatic, two-arm, multicentre RCT comparing the impact of 6 months INHD to conventional haemodialysis (thrice-weekly daytime in-centre haemodialysis, 3.5-5 h per session). The primary outcome is the total score from the Kidney Disease Quality of Life tool at 6 months. Secondary outcomes include sleep and cognitive function, measures of safety, adherence to dialysis and impact on clinical parameters. There is an embedded Process Evaluation to assess implementation, health economic modelling and a QuinteT Recruitment Intervention to understand factors that influence recruitment and retention. Adults (≥ 18 years old) who have been established on haemodialysis for > 3 months are eligible to participate.

DISCUSSION: There are 68,000 adults in the UK that need kidney replacement therapy (KRT), with in-centre haemodialysis the treatment modality for over a third of cases. HRQoL is an independent predictor of hospitalisation and mortality in individuals on maintenance dialysis. Haemodialysis is associated with poor HRQoL in comparison to the general population. INHD has the potential to improve HRQoL. Vigorous RCT evidence of effectiveness is lacking. The NightLife study is an essential step in the understanding of dialysis therapies and will guide patient-centred decisions regarding KRT in the future.

TRIAL REGISTRATION: Trial registration number: ISRCTN87042063. Registered: 14/07/2020.

Original languageEnglish
Article number522
JournalTrials
Volume24
Issue number1
DOIs
Publication statusPublished - 12 Aug 2023

Bibliographical note

Funding Information:
LJG is supported by the National Institute for Health and Care Research (NIHR) Applied Research Collaboration East Midlands (ARC EM) and Leicester NIHR Biomedical Research Centre (BRC). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. SM is supported by Medtech NIHR D4D MedTech & In-Vitro diagnostics Co-operatives (MICs).

Funding Information:
We are incredibly grateful to the patients participating in the NightLife study and for their contribution to the PPIE forum. We would like to thank all members of the Trial Steering Committee and Data Safety and Monitoring Committee. LJG is supported by the National Institute for Health and Care Research (NIHR) Applied Research Collaboration East Midlands (ARC EM) and Leicester NIHR Biomedical Research Centre (BRC). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. SM is supported by Medtech NIHR D4D MedTech & In-Vitro diagnostics Co-operatives (MICs). We very much appreciate all the hard work of our collaborating centres and the wider NightLife study group: Hannah M Worboys, University of Leicester; Ghazala Waheed, Leicester Clinical Trials Unit; Cathy Young, Leicester Clinical Trials Unit; Dr Kateryna MacConaill, University Hospitals of Leicester NHS Trust; Bindiyaben Chavda, Leicester Clinical Trials Unit; Theresia Bonsell, Leicester Clinical Trials Unit; Andrew Ryder, Leicester Clinical Trials Unit; Dr Judi Graham, Southern Health and Social Care Trust; Dr Tim Shipley, South Tees Hospital NHS Foundation Trust; Dr Sokratis Stoumpos, NHS Greater Glasgow and Clyde; Dr Helen Aston, King’s College Hospital NHS Foundation Trust; Dr Camilla Pillay, King’s College Hospital NHS Foundation Trust; Dr Abdulfattah Alejmi, Betsi Cadwaladr University Health Board.

Funding Information:
The NightLife study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) award [HTA (NIHR127440)]. The funding body had no role in the design of the NightLife study, the collection of data or the writing of this paper, nor will the funding body have a role in the analysis, interpretation of data or writing of future manuscripts. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health and Social Care.

Publisher Copyright:
© 2023, BioMed Central Ltd., part of Springer Nature.

Keywords

  • Adult
  • Humans
  • Adolescent
  • Cost-Benefit Analysis
  • Renal Dialysis/adverse effects
  • Renal Replacement Therapy
  • Quality of Life
  • Randomized Controlled Trials as Topic

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