The effect of a novel, digital physical activity and emotional well-being intervention on health-related quality of life in people with chronic kidney disease: trial design and baseline data from a multicentre prospective, wait-list randomised controlled trial (kidney BEAM)

BMC Nephrology

Study Protocol

M. W Taal¹  J. O. Burton²  M. P.M Graham-Brown²  R. E Billany²  N Cooper²  K McCafferty³  E Asghari⁴  S Bhandari⁵  M Jesky⁶  A Hamilton⁷  V Deelchand⁸  P. A Kalra⁹  C Sothinathan^1,10  A. C Nixon^1,11  J Tollitt^1,12  K Bramham^1,13  P Koufaki^1,14  J Campbell^1,15  J.H Macdonald^1,16  T. J Wilkinson^1,17  J Chilcot^1,18  Hannah M.L Young^1,19  D.C Wheeler^2,20  J Briggs^2,21  S. A Greenwood^2,21  C. G Walklin^2,21  H Noble^2,22  E. M Castle^2,23  N Bishop^2,24  Z. L. Saynor^2,25 

[1] Centre for Kidney Research and Innovation, University of Nottingham, Nottingham, UK;Department of Health Sciences, University of Leicester, Leicester, UK;Department of Nephrology, Barts Health NHS Trust, London, UK;Department of Nephrology, Guy’s and St Thomas’ NHS Trust, London, UK;Department of Nephrology, Hull University Teaching Hospitals NHS Trust, Hull, UK;Department of Nephrology, Nottingham NHS Trust, Nottingham, UK;Department of Nephrology, Royal Exeter Hospital, Devon, UK;Department of Nephrology, Royal Free Hospital, London, UK;Department of Nephrology, Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK;Department of Physiotherapy, Chelsea and Westminster NHS Trust, London, UK;Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK;Division of Cardiovascular Sciences, The University of Manchester, Manchester, UK;Department of Renal Medicine, University College London, London, UK;Department of Women’s Health, King’s College London, London, UK;Dietetics, Nutrition and Biological Sciences, Queen Margaret University, Edinburgh, UK;Faculty of Health, Education and Society, University of Northampton, Northampton, UK;Faculty of life sciences and medicine, King’s College London, London, UK;Institute for Applied Human Physiology, Bangor University, Bangor, Gwynedd, UK;Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK;Leicester Diabetes Centre, Leicester General Hospital, Leicester, UK;National Institute of Health Research Leicester Biomedical Research Centre, Leicester, UK;Renal Therapies, King’s College Hospital NHS Trust, London, UK;School of Nursing and Midwifery, Queen’s University, Belfast, UK;School of Physiotherapy, Department of Health Sciences, Brunel University, London, UK;School of Sport, Exercise and Health Sciences, University of Loughborough, Loughborough, UK;School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, UK;

关键词: KDQoL-SF;    SF-36;    e-health;    Telemedicine;    Digital health;    Mixed-methods;    Quality of life;   

DOI  :  10.1186/s12882-023-03173-7

 received in 2023-03-29, accepted in 2023-04-18,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPhysical activity and emotional self-management has the potential to enhance health-related quality of life (HRQoL), but few people with chronic kidney disease (CKD) have access to resources and support. The Kidney BEAM trial aims to evaluate whether an evidence-based physical activity and emotional wellbeing self-management programme (Kidney BEAM) leads to improvements in HRQoL in people with CKD.MethodsThis was a prospective, multicentre, randomised waitlist-controlled trial, with health economic analysis and nested qualitative studies. In total, three hundred and four adults with established CKD were recruited from 11 UK kidney units. Participants were randomly assigned to the intervention (Kidney BEAM) or a wait list control group (1:1). The primary outcome was the between-group difference in Kidney Disease Quality of Life (KDQoL) mental component summary score (MCS) at 12 weeks. Secondary outcomes included the KDQoL physical component summary score, kidney-specific scores, fatigue, life participation, depression and anxiety, physical function, clinical chemistry, healthcare utilisation and harms. All outcomes were measured at baseline and 12 weeks, with long-term HRQoL and adherence also collected at six months follow-up. A nested qualitative study explored experience and impact of using Kidney BEAM.Results340 participants were randomised to Kidney BEAM (n = 173) and waiting list (n = 167) groups. There were 96 (55%) and 89 (53%) males in the intervention and waiting list groups respectively, and the mean (SD) age was 53 (14) years in both groups. Ethnicity, body mass, CKD stage, and history of diabetes and hypertension were comparable across groups. The mean (SD) of the MCS was similar in both groups, 44.7 (10.8) and 45.9 (10.6) in the intervention and waiting list groups respectively.ConclusionResults from this trial will establish whether the Kidney BEAM self management programme is a cost-effective method of enhancing mental and physical wellbeing of people with CKD.Trial RegistrationNCT04872933. Registered 5th May 2021.

【 授权许可】

CC BY   
© The Author(s) 2023

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