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)

Abstract

Background Physical 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. Methods This 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. Results 340 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. Conclusion Results 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 Registration NCT04872933. Registered 5th May 2021.

Lifestyle interventions delivered by eHealth in chronic kidney disease: A scoping review

“…Moreover, these trials should include implementation work or pragmatic and adaptive designs that take into account feasibility, as the widespread uptake of eHealth interventions is currently limited [ 15 ]. That said, there were two included protocol publications [ 35 , 36 ] for appropriately powered RCTs investigating the effect and engagement of web-based self-management platforms, they were co-designed with relevant stakeholders so that they can be embedded as part of usual clinical care should they prove efficacious. There was no cost-effectiveness analysis included in the current review, although eHealth interventions may have the potential to reduce cost in the long-term they will undoubtedly require upfront investment.…”

The development and internal pilot trial of a digital physical activity and emotional well-being intervention (Kidney BEAM) for people with chronic kidney disease

“…Strategies that have proven beneficial to engaging frailer participants in other evaluations of DHIs include providing access to technology, providing support to increase ‘readiness’ to use the intervention, addressing concerns about injury, social isolation and security and avoiding stigmatisation 62 , 63 . As part of the evaluation of Kidney BEAM, we are conducting a qualitative sub-study 12 which will explore these challenges in people who declined to participate in the trial. The findings of this sub-study, alongside a substudy specifically examining the role and effectiveness of Kidney BEAM during the intradialytic period for people receiving HD, will more comprehensively inform strategies to address inequality of access and to improve the reach of Kidney BEAM.…”

“…Centres selected were those first open to recruitment. Inclusion and exclusion criteria mirrored the definitive trial (Table 1 ) 12 . CKD was defined as kidney damage or glomerular filtration rate (GFR) < 60 mL/min/1.73 m(2) for 3 months or more, irrespective of cause 19 .…”

“…Kidney BEAM is a DHI which has been co-developed with people with CKD to support physical activity and emotional well-being self-management. A multicentre prospective, wait-list randomised controlled trial (RCT) will evaluate whether Kidney BEAM improves HRQoL 12 . The aims of this trial’s internal pilot were to (1) establish the feasibility of a RCT investigating the effectiveness of Kidney BEAM and (2) explore participants’ perceptions of trial and intervention acceptability.…”

Exercise as a therapeutic intervention in chronic kidney disease: are we nearly there yet?

“…Given that positive changes in patient activation can result in better self-management and facilitate behaviour change and engagement with health-promoting behaviours, including regular physical activity [ 8 ], it is not surprising that self-management interventions with a focus on physical activity and exercise behaviours have gained increasing attention. Whilst we await findings from self-management interventions promoting physical activity in CKD [ 9 ▪ , 10 ▪ , 11 ▪ , 12 ], similar interventions in other long-term conditions have demonstrated beneficial effects on physical activity behaviours [ 13 , 14 ]. However, in those with multimorbidity, reductions in physical activity levels have been observed [ 15 ].…”