A randomised controlled pilot trial protocol for patient led cognitive gamified training during haemodialysis

Disruptions in cognitive function have been reported in individuals undergoing haemodialysis and those with chronic kidney disease. This pilot study protocol primarily assesses the feasibility and acceptability of using mobile cognitive gaming apps for patient-led cognitive training during haemodialysis sessions. The protocol consists of three phases: (1) reviewing and evaluating available cognitive gaming apps, (2) conducting focus groups/interviews with people with kidney disease to determine app preferences, and (3) undertaking a quasi-experimental randomised controlled trial to compare cognitive outcomes between a patient-led app intervention group and a standard care control group over four months. Primary outcomes will include changes in cognitive test scores [Montreal Cognitive Assessment (MoCA), Modified Mini-Mental State Exam (3MSE), Rapid Objective Working Memory Assessment (ROWMA)], while secondary outcomes will encompass quality of life measures [Patient-Reported Outcomes Measurement (PROM) Kidney Disease Quality of Life Short Form (KDQoL-SF™) v 1.3, Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Instrument, European Quality of Life Five Dimension (EQ-5D)]. If demonstrated to be effective, this novel method of utilising gamified cognitive training applications could potentially mitigate cognitive decline and improve the well-being of people receiving haemodialysis without necessitating significant clinical resources. The findings from this research will guide the development of a larger definitive randomised trial in the future.