Title {1} | 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 |
Trial Registration {2a and 2b} |
Trial registration number: ISRCTN87042063 Prospectively registered: 14/07/2020 |
Protocol version {3} | Version 4, 09/02/2023 |
Funding {4} | The NightLife study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) award [HTA (NIHR127440)] |
Author details {5a} | Department of Cardiovascular Sciences, University of Leicester; John Walls Renal Unit, University Hospitals of Leicester NHS Trust; King’s Kidney Care, King’s College Hospital; Department of Women and Children’s Health, Faculty of Life Sciences and Medicine, King’s College London; Leicester Clinical Trials Unit, University of Leicester; School of Sociology and Social Policy, University of Nottingham; Bristol Population Health Science Institute, University of Bristol Medical School; Department of Population Health Sciences, University of Leicester; Usher Institute, College of Medicine and Veterinary Medicine, University of Edinburgh; Health Economics and Decision Science, School of Health and Related Research, University of Sheffield; Sheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation Trust; Institute of Cardiovascular and Medical Sciences, University of Glasgow; Manchester Institute of Nephrology and Transplantation; Manchester Academic Health Science Centre, Research and Innovation, Manchester University NHS Foundation Trust; Cardiovascular Research Centre, University of Leicester; Warren-Charnock Associates; NightLife study group – see acknowledgments |
Name and contact information for the trial sponsor {5b} |
Research Governance Office Research & Enterprise Division University of Leicester University Road Leicester LE1 7RH UK rgosponsor@leicester.ac.uk |
Role of sponsor {5c} | The Sponsor will be responsible for overall oversight of the study. The Sponsor will delegate duties to other parties, including Leicester Clinical Trials Unit, this delegation will be formally documented. The Sponsor will not be part of the study conduct, data analysis and interpretation, manuscript writing, and dissemination of results |