title: Study protocol for the recreational stimulation for elders as a vehicle to resolve delirium superimposed on dementia (Reserve For DSD) trial.
abstract: BACKGROUND
  Delirium is a state of confusion characterized by an acute and fluctuating decline in cognitive functioning. Delirium is common and deadly in older adults with dementia, and is often referred to as delirium superimposed on dementia, or DSD. Interventions that treat DSD are not well-developed because the mechanisms involved in its etiology are not completely understood. We have developed a theory-based intervention for DSD that is derived from the literature on cognitive reserve and based on our prior interdisciplinary work on delirium, recreational activities, and cognitive stimulation in people with dementia. Our preliminary work indicate that use of simple, cognitively stimulating activities may help resolve delirium by helping to focus inattention, the primary neuropsychological deficit in delirium. Our primary aim in this trial is to test the efficacy of Recreational Stimulation for Elders as a Vehicle to resolve DSD (RESERVE- DSD).
  
  
  METHODS
  This randomized repeated measures clinical trial will involve participants being recruited and enrolled at the time of admission to post acute care. We will randomize 256 subjects to intervention (RESERVE-DSD) or control (usual care). Intervention subjects will receive 30-minute sessions of tailored cognitively stimulating recreational activities for up to 30 days. We hypothesize that subjects who receive RESERVE-DSD will have: decreased severity and duration of delirium; greater gains in attention, orientation, memory, abstract thinking, and executive functioning; and greater gains in physical function compared to subjects with DSD who receive usual care. We will also evaluate potential moderators of intervention efficacy (lifetime of complex mental activities and APOE status). Our secondary aim is to describe the costs associated with RESERVE-DSD.
  
  
  CONCLUSIONS
  Our theory-based intervention, which uses simple, inexpensive recreational activities for delivering cognitive stimulation, is innovative because, to our knowledge it has not been tested as a treatment for DSD. This novel intervention for DSD builds on our prior delirium, recreational activity and cognitive stimulation research, and draws support from cognitive reserve theory.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01267682
authors.affiliation: School of Nursing, Pennsylvania State University, University Park, PA, USA. amk20@psu.edu
authors.forename: Ann M
authors.initials: AM
authors.lastname: Kolanowski
authors.forename: Donna M
authors.initials: DM
authors.lastname: Fick
authors.forename: Mark S
authors.initials: MS
authors.lastname: Litaker
authors.forename: Linda
authors.initials: L
authors.lastname: Clare
authors.forename: Doug
authors.initials: D
authors.lastname: Leslie
authors.forename: Malaz
authors.initials: M
authors.lastname: Boustani
mesh_terms: D000367:Age Factors; D000368:Aged; D001288:Attention; D003071:Cognition; D003693:Delirium / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D003704:Dementia / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D056344:Executive Function; D006707:Homes for the Aged; D006801:Humans; D008568:Memory; D009483:Neuropsychological Tests; D009735:Nursing Homes; D009949:Orientation; D010414:Pennsylvania; D011569:Psychiatric Status Rating Scales; D057173:Recreation Therapy; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome