Protocol for a multicentre, randomised controlled trial of computerised cognitive rehabilitation in survivors of critical illness: the RETURN-III study

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INTRODUCTION: Cognitive impairment after critical illness is a common occurrence that has a profound impact on millions of people worldwide each year. Currently, no interventions after critical illness have been found to promote cognitive recovery. Cognitive training has shown promise in other populations (eg, community-dwelling adults), predominantly in improving the trained cognitive domain (eg, memory, reasoning or executive function). In pilot work, in-person cognitive training with intensive care unit (ICU) survivors was found to not only improve the trained domain but also may reduce disabilities in daily function. Computerised cognitive rehabilitation (CCR) is a more scalable option, which we have demonstrated the feasibility of use among ICU survivors. Whether CCR is efficacious in ICU survivors remains unknown. METHODS AND ANALYSIS: The Returning to Everyday Tasks Utilising Rehabilitation Networks-III (RETURN-III) study is a multicentre, randomised, double-blinded, parallel group controlled trial testing the hypothesis that CCR versus active control will result in less cognitive impairment after critical illness. Adult patients who recently experienced acute respiratory failure or shock in medical and surgical ICUs at two hospitals in Nashville (TN, USA) will be enrolled. Participants will be randomised within 12 weeks of hospital discharge to a 12-week home-based programme of CCR (or control), with the goal of five 30 min sessions per week. In-person assessments will be performed at baseline, 3 months and 12 months after randomisation. The primary outcome is global cognitive function 3 months after randomisation using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score. Secondary outcomes will include 12-month RBANS global cognitive function, 3-month and 12-month subjective cognition by the Cognitive Self-Report Questionnaire, daily function related to cognition by the Functional Activities Questionnaire and processing speed/executive function by Trail Making Test part B. With an anticipated enrolment of 160 patients, the study will have at least 80% power to detect a 7-point or higher difference in RBANS cognition scores between the two groups (<0.5 SD based on age-adjusted population norms) with a type 1 error rate of 5%. ETHICS AND DISSEMINATION: The RETURN-III study was approved by the institutional review boards at each participating site. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences following completion of data collection. TRIAL REGISTRATION NUMBER: NCT04353804.

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