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Remote digital health interventions to enhance physical activity provide a potential solution to deliver kidney-specific physical rehabilitation at scale but there is a need for these interventions to be cost efficient and evidence-based. The Kidney BEAM trial evaluated the clinical effect and health economic implications of a 6-month physical activity digital health intervention on health-related quality of life and healthcare utilisation.
In a multicentre (11 UK centres), randomised controlled trial, we assigned 340 adult participants with CKD to either the KIDNEY BEAM intervention or a wait-list control group. We measured the difference in the Kidney Disease Quality of Life Short Form 1.3 Mental Component Summary (KDQoL-SF1.3 MCS), the KDQoL-SF1.3 Physical Component Summary (PCS) and the European Quality of Life 5 dimension, 3 level (EQ5D-3L) utility score between baseline and 24-weeks. Healthcare utilisation was also measured at the same time-points. Outcomes, as per pre-specified statistical analysis plan, were first analysed with an intention-to-treat (Last Observation Carried Forward) approach using an analysis of covariance model, with baseline measures and age as covariates. Per protocol analyses were also completed to assess efficacy under ideal conditions.
Two hundred and twenty-nine participants completed the trial at 24 weeks (Kidney BEAM: n=93; waitlist control: n=136). All 340 randomised participants were included in the intention-to treat analyses. At 24 weeks there was a significant difference in mean adjusted change in KDQoL MCS score between Kidney BEAM and waitlist control of 5.9 {95% confidence interval: 4.4 to 7.5} arbitrary units (p<0.0001). KDQoL burden of kidney disease (p=0.0017), quality of social interaction (p<0.0001), sleep (p<0.0001), physical functioning (p=0.0003), role physical (p=0.014), pain (p=0.0002), general health (p=0.0018), emotional wellbeing (p<0.0001), role emotional (p=0.0058), social function (p<0.0001) and energy/fatigue (p<0.0001) all improved in favour of the intervention. There was a significant mean adjusted change in the EQ5D-3L utility score of 1.0 {95% confidence interval: 0.007 to 0.13} unit (p<0.0001) in favour of the intervention. Data from the adjusted base-case within trial analysis showed a 93% and 98% chance of KB being cost-effective compared with control participants at a willingness to pay of £20,000 and £30,000 per quality-adjusted life year (QALY) gained.
Our results demonstrate that the Kidney BEAM physical activity and digital health intervention is an effective intervention to improve HRQoL for people living with CKD. The results of this trial will inform future clinical practice and guidelines for the international community.