Reserve For Delirium Superimposed On Dementia (DSD)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Penn State University
- Enrollment
- 283
- Locations
- 18
- Primary Endpoint
- Confusion Assessment Method
Study Overview
Brief Summary
The purpose of this study is to test the effectiveness of cognitively stimulating activities for resolving delirium in people with dementia.
Detailed Description
The primary aim in this RCT is to test the efficacy of Recreational Stimulation for Elders as a Vehicle to resolve DSD (RESERVE- DSD). The investigators will randomize 256 subjects, newly admitted to post acute care, 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. The investigators 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. The investigators will also evaluate potential moderators of intervention efficacy (lifetime of complex mental activities and APOE status). The secondary aim is to describe the costs associated with RESERVE-DSD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •presence of delirium
- •mild to moderate cognitive impairments
- •65 years of age or older
- •English speaking
- •community-dwelling
- •legally authorized representative available
Exclusion Criteria
- •severe vision or hearing problems
- •diagnosis of
- •major depression
- •Parkinson's with Lewy Body disease
- •Huntington's disease
- •normal pressure hydrocephalus
- •seizure disorder
- •subdural hematoma
- •head trauma
- •known structural brain abnormalities
- •acute CVA/stroke
- •acute psychiatric condition
- •life expectancy < 6 months
Outcomes
Primary Outcomes
Confusion Assessment Method
Time Frame: Averaged over 30 days or until discharge, whichever comes first
Delirium Rating Scale
Time Frame: Averaged over 30 days or until discharge, whichever comes first
Secondary Outcomes
- Executive Function(Averaged over 30 days or until discharge, whichever comes first)
- Physical Function(Averaged over 30 days or until discharge, whichever comes first)
- Memory(Averaged over 30 days or until discharge, whichever comes first)
- Abstract Thinking(Averaged over 30 days or until discharge, whichever comes first)
- Attention(Averaged over 30 days or until discharge, whichever comes first)
- Orientation(Averaged over 30 days or until discharge, whichever comes first)
Investigators
Ann Kolanowski
Professor of Nursing
Penn State University