The Everyday Function Intervention Trial
Condition: Cognitive Change; Cognitive Impairment; Healthy Aging; Dementia
MeSH terms: Dementia; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Loss of independence, cognitive decline, and difficulties in everyday function are areas of
      great concern for older adults and their families. From a public health perspective,
      successful efforts that enable older adults to age within their homes, as compared to nursing
      homes, will save an estimated $80 billion dollars per year. Cognitive training is one
      intervention that maintains cognition, everyday function, and health. Although clearly an
      important and effective intervention, the mediators, or mechanisms, underlying this program
      are unknown. Our overall objective is to assess the cognitive and psychosocial factors within
      daily life that account for the transfer of one form of cognitive training to everyday
      function. This exploratory double-blind trial will randomize older adults to 20 hours of
      cognitive training or cognitively stimulating activities. The investigators will assess
      cognitive and psychosocial factors before, during, and after training within daily life. The
      investigators will then compare such factors and assess how they impact the transfer of
      cognitive training to everyday functioning. The investigators will also include an eligible
      sub group of the EFIT participants who will have functional MRI brain scans and sleep
      evaluation using the Sleep Profiler, a clinically approved device, at pre and post brain
      training. The investigators will also monitor daily activity in this sub group using FitBIt
      watches.

      Our central hypothesis is that improvements in daily processing speed and attention, key
      components of higher order cognitive functions, will have the strongest relationship with
      everyday function changes. This exploratory study is the first of its kind and will be used
      to provide important data relevant to a future larger randomized controlled trial examining
      mediators of cognitive training in a representative sample of adults. Additionally, all data
      collection, with the exception of MRI, can be completed remotely within the participant's
      home. This information will assist in the future development of more effective home- and
      community-based interventions that maintain everyday function.
    

Detailed description: 
      The EFIT study is a randomized clinical trial to explore moderators and mechanisms underlying
      the transfer of one cognitive training program to maintained cognition and everyday function.
      100 participants will complete three traditional assessments of cognitive, psychosocial, and
      lifestyle assessments on a study-provided laptop at baseline, post-test, and three-month
      follow-up. Across this study period, participants will complete daily cognitive,
      psychosocial, and health assessments using a study-provided smartphone. Between baseline and
      post-test, participants will be randomized to one of two arms: cognitive training or an
      active control. Both groups will complete 20 hours of activities on the study-provided laptop
      across a ten week period.

      A subsample of 40 participants will also complete three additional measures. First, they will
      be provided a FitBit and be asked to wear the FitBit across the study period. Second, sleep
      measures will be obtained across two nights at baseline and post-test using an at home sleep
      monitor, which is clinically approved, and evaluated by a physician specializing in sleep.
      Finally, this subsample will also complete a fMRI session at baseline and posttest.

      Except for the fMRI sessions, all data collection is complete remotely within the
      participants' homes.
    

Intervention name(s): Cognitive Training; Cognitive Stimulating Activities
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 20 hours of computerized activities designed to improve processing speed and divided attention; 20 hours of traditional computer games
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Brain training; Cognitive training; Brain health; Everyday functioning