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Clinical Trials/NCT01267682
NCT01267682
Completed
Phase 2

Reserve For Delirium Superimposed On Dementia (DSD)

Penn State University9 sites in 1 country283 target enrollmentJanuary 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Delirium
Sponsor
Penn State University
Enrollment
283
Locations
9
Primary Endpoint
Confusion Assessment Method
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ann Kolanowski

Professor of Nursing

Penn State University

Eligibility Criteria

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

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)

Study Sites (9)

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