The Everyday Function Intervention Trial (EFIT) protocol: A randomized clinical trial

Preserving cognition and everyday function is essential for maintaining independence and reducing risk of Alzheimer's disease and related dementias (ADRD). Useful Field of View training (UFOVt) is a computerized cognitive training program that achieves these goals; however, the mechanisms underlying UFOVt are unclear. The Everyday Function Intervention Trial (EFIT) is a double-blind randomized clinical controlled trial designed to assess potential cognitive, psychosocial, biological, and lifestyle mechanisms underlying UFOVt. In the current paper, we outline the protocol employed in EFIT.

Community-dwelling older adults (N = 96) completed cognitive, psychosocial, health, and lifestyle assessments on a study-provided laptop at baseline, post-test, and three-month follow-up, along with additional daily cognitive, psychosocial, health, and lifestyle assessments on a study-provided smartphone throughout the study period. Following baseline, participants were randomized into the cognitive training or active control group completing twenty hours of brain games across ten weeks. A subsample (n = 38) completed additional activities: wearing a FitBit, undergoing MRI scans, and using at-home sleep monitors across two nights at baseline and post-test. Aside from MRI sessions, participants completed study activities remotely.

EFIT's design included several novel features: ecological momentary assessment; remote data collection; evaluation of mediators before, during, and after training; training tasks targeting one cognitive domain at a time; performance-based and self-reported everyday function and instrumental activities of daily living measures; use of an active control group; and an exploratory multilevel modeling analytic approach. These features will provide an in-depth understanding of intervention transfer effects and guide the design of future cognitive interventions.