A pilot study is exploring the use of cognitive training apps to combat cognitive decline in patients undergoing hemodialysis. The trial, conducted at Hull University Teaching Hospitals NHS Trust, investigates the feasibility and effectiveness of patient-led cognitive gamified training (CGT) during hemodialysis sessions. This intervention aims to provide a readily accessible and engaging method for patients to maintain cognitive function.
Trial Design and Intervention
The study employs a single-center, two-armed pseudo-randomized controlled design. Participants are assigned to either an intervention group, receiving CGT via mobile apps, or a control group, receiving standard care. The CGT intervention is delivered during the first 1-2 hours of hemodialysis sessions, three times per week, for 30 minutes each session, over a four-month period. Patients use tablets to engage with cognitive training apps targeting memory, attention, problem-solving, and processing speed. The apps are selected based on a review of available options and feedback from patient focus groups, including representatives from Kidney Patient Associations and Kidney Care UK.
Study Population and Methodology
The trial recruits individuals currently receiving hemodialysis therapy. Baseline assessments, including the Montreal Cognitive Assessment (MoCA), Modified Mini-Mental State Exam (3MSE), and Rapid Objective Working Memory Assessment (ROWMA), are conducted to evaluate cognitive function. Quality of life is assessed using the Kidney Disease Quality of Life Short Form (KDQoL-SF™), PROMIS Global Health Instrument, and European Quality of Life Five Dimension (EQ-5D) questionnaires. These assessments are repeated after the four-month intervention period to measure changes in cognitive and behavioral test scores.
Outcomes and Statistical Analysis
The primary outcome is the change in cognitive test results (MoCA, 3MSE, and ROWMA) between baseline and follow-up assessments in the intervention group compared to the control group. Secondary outcomes include changes in behavioral test scores (KDQoL-SF™, PROMIS, and EQ-5D). Statistical analysis will be performed using IBM SPSS Statistics to compare within-group and between-group differences. The study also includes subgroup analysis to explore the potential effects of CGT based on participants’ baseline memory and executive function.
Addressing Limitations
The study acknowledges the limitation of not being able to blind participants or assessors due to the nature of the intervention. To mitigate potential bias, standardized assessment protocols, objective measures, and multiple assessors are used. The study also emphasizes the importance of thoroughly discussing this limitation and its potential implications in the final report.
Ethical and Regulatory Considerations
The trial adheres to the standards of ICH-Good Clinical Practice (GCP) and the Research Governance Framework for Health and Social Care. Ethical approval was granted by the National Research Ethics Service Committee London - Harrow. All participants provide written informed consent prior to enrollment.
