The clinical value and cost effectiveness of a 6-month digital health intervention to improve physical activity and mental health-related quality of life in people with chronic kidney disease (Kidney BEAM): A multi-centre, randomised controlled trial

Abstract There is inequity in provision of physical rehabilitation services for people living with chronic kidney disease (CKD). The Kidney BEAM trial evaluated the clinical value and cost effectiveness of a physical activity digital health intervention in CKD. In a single-blind, 11 centre, randomised controlled trial, 340 adult participants with CKD were randomly assigned to either the Kidney BEAM physical activity digital health intervention or a waitlist control. The primary outcomes were the difference in the Kidney Disease Quality of Life Short Form 1.3 Mental Component Summary (KDQoL-SF1.3 MCS) between intervention and control groups at 6 months, and cost-effectiveness. At 6 months there was a significant difference in mean adjusted change in KDQoL MCS score between Kidney BEAM and waitlist control (intention-to-treat adjusted mean: 5.9 {95% confidence interval: 4.4 to 7.5} arbitrary units, p<0.0001), and a 93% and 98% chance of the intervention being cost-effective at a willingness to pay threshold of £20,000 and £30,000 per quality-adjusted life year gained. In conclusion, the Kidney BEAM physical activity digital health intervention is a clinically valuable and cost-effective means to improve mental health related quality of life in people with CKD (trial registration no. NCT04872933).