Evaluating the effect of a digital health intervention to enhance physical activity in people with chronic kidney disease (Kidney BEAM): a multicentre, randomised controlled trial in the UK

Sharlene A Greenwood; Hannah M L Young; Juliet Briggs; Ellen M Castle; Christy Walklin; Lynda Haggis; Caitlin Balkin; Elham Asgari; Sunil Bhandari; James O Burton; Roseanne E Billany; Nicolette C Bishop; Kate Bramham; Jackie Campbell; Joseph Chilcot; Nicola J Cooper; Vashist Deelchand; Matthew P M Graham-Brown; Alexander Hamilton; Mark Jesky; Philip A Kalra; Pelagia Koufaki; Kieran McCafferty; Andrew C Nixon; Helen Noble; Zoe Saynor; Maarten W Taal; James Tollit; David C Wheeler; Thomas J Wilkinson; Hannah Worboys; Jamie H Macdonald

doi:10.1016/S2589-7500(23)00204-2

Evaluating the effect of a digital health intervention to enhance physical activity in people with chronic kidney disease (Kidney BEAM): a multicentre, randomised controlled trial in the UK

Lancet Digit Health. 2024 Jan;6(1):e23-e32. doi: 10.1016/S2589-7500(23)00204-2. Epub 2023 Nov 14.

Authors

Sharlene A Greenwood¹, Hannah M L Young², Juliet Briggs³, Ellen M Castle⁴, Christy Walklin³, Lynda Haggis³, Caitlin Balkin³, Elham Asgari⁵, Sunil Bhandari⁶, James O Burton⁷, Roseanne E Billany⁷, Nicolette C Bishop⁸, Kate Bramham⁹, Jackie Campbell¹⁰, Joseph Chilcot¹¹, Nicola J Cooper¹², Vashist Deelchand¹³, Matthew P M Graham-Brown⁷, Alexander Hamilton¹⁴, Mark Jesky¹⁵, Philip A Kalra¹⁶, Pelagia Koufaki¹⁷, Kieran McCafferty¹⁸, Andrew C Nixon¹⁹, Helen Noble²⁰, Zoe Saynor²¹, Maarten W Taal²², James Tollit¹⁶, David C Wheeler²³, Thomas J Wilkinson²⁴, Hannah Worboys¹², Jamie H Macdonald²⁵

Affiliations

¹ Department of Renal Medicine, King's College Hospital NHS Trust, London, UK; Renal Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK. Electronic address: [email protected].
² NIHR Leicester Biomedical Research Centre, Leicester, UK; Leicester Diabetes Centre, University of Leicester, Leicester, UK; Physiotherapy Department, University Hospitals of Leicester NHS Trust, Leicester, UK.
³ Department of Renal Medicine, King's College Hospital NHS Trust, London, UK.
⁴ School of Physiotherapy, Department of Health Sciences, Brunel University, London, UK.
⁵ Department of Renal Medicine, Guy's and St Thomas' NHS Trust, London, UK.
⁶ Department of Renal Medicine, Hull University Teaching Hospitals NHS Trust, Hull, UK.
⁷ NIHR Leicester Biomedical Research Centre, Leicester, UK; Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.
⁸ School of Sport Exercise and Health Sciences, Loughborough University, Loughborough, UK.
⁹ Women's Health, King's College London, London, UK.
¹⁰ Faculty of Health, Education and Society, University of Northampton, Northampton, UK.
¹¹ Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
¹² Department of Population Health Sciences, University of Leicester, Leicester, UK.
¹³ Department of Renal Medicine, Royal Free Hospital, London, UK.
¹⁴ Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK.
¹⁵ Department of Renal Medicine, Nottingham NHS Trust, Nottingham, UK.
¹⁶ Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.
¹⁷ Department of Renal Medicine, Queen Margaret University, Edinburgh, UK.
¹⁸ Department of Renal Medicine, Barts Health NHS Trust, London, UK.
¹⁹ Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK; Division of Cardiovascular Sciences, University of Manchester, Manchester, UK.
²⁰ School of Nursing and Midwifery, Queen's University, Belfast, UK.
²¹ School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, UK.
²² Centre for Kidney Research and Innovation, School of Medicine, University of Nottingham, Nottingham, UK.
²³ Department of Renal Medicine, University College London, London, UK.
²⁴ NIHR Leicester Biomedical Research Centre, Leicester, UK; Leicester Diabetes Centre, University of Leicester, Leicester, UK.
²⁵ Institute for Applied Human Physiology, Bangor University, Bangor, UK.

PMID: 37968170
DOI: 10.1016/S2589-7500(23)00204-2

Abstract

Background: Remote digital health interventions to enhance physical activity provide a potential solution to improve the sedentary behaviour, physical inactivity, and poor health-related quality of life that are typical of chronic conditions, particularly for people with chronic kidney disease. However, there is a need for high-quality evidence to support implementation in clinical practice. The Kidney BEAM trial evaluated the clinical effect of a 12-week physical activity digital health intervention on health-related quality of life.

Methods: In a single-blind, randomised controlled trial conducted at 11 centres in the UK, adult participants (aged ≥18 years) with chronic kidney disease were recruited and randomly assigned (1:1) to the Kidney BEAM physical activity digital health intervention or a waiting list control group. Randomisation was performed with a web-based system, in randomly permuted blocks of six. Outcome assessors were masked to treatment allocation. The primary outcome was the difference in the Kidney Disease Quality of Life Short Form version 1.3 Mental Component Summary (KDQoL-SF1.3 MCS) between baseline and 12 weeks. The trial was powered to detect a clinically meaningful difference of 3 arbitrary units (AU) in KDQoL-SF1.3 MCS. Outcomes were analysed by an intention-to-treat approach using an analysis of covariance model, with baseline measures and age as covariates. The trial was registered with ClinicalTrials.gov, NCT04872933.

Findings: Between May 6, 2021, and Oct 30, 2022, 1102 individuals were assessed for eligibility, of whom 340 participants were enrolled and randomly assigned to the Kidney BEAM intervention group (n=173) or the waiting list control group (n=167). 268 participants completed the trial (112 in the Kidney BEAM group and 156 in the waiting list control group). All 340 randomly assigned participants were included in the intention-to treat population. At 12 weeks, there was a significant improvement in KDQoL-SF.13 MCS score in the Kidney BEAM group (from mean 44·6 AU [SD 10·8] at baseline to 47·0 AU [10·6] at 12 weeks) compared with the waiting list control group (from 46·1 AU [10·5] to 45·0 AU [10·1]; between-group difference of 3·1 AU [95% CI 1·8-4·4]; p<0·0001).

Interpretation: The Kidney BEAM physical activity platform is an efficacious digital health intervention to improve mental health-related quality of life in patients with chronic kidney disease. These findings could facilitate the incorporation of remote digital health interventions into clinical practice and offer a potential intervention worthy of investigation in other chronic conditions.

Funding: Kidney Research UK.

Publication types

Randomized Controlled Trial
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Adult
Chronic Disease
Digital Health*
Exercise
Humans
Kidney
Quality of Life
Renal Insufficiency, Chronic* / therapy
Single-Blind Method
Treatment Outcome
United Kingdom

Associated data

ClinicalTrials.gov/NCT04872933