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Completed

NCT Number: NCT01267682

Cognitive Intervention For Delirium in Dementia

The purpose of this study is to test the effectiveness of cognitively stimulating activities for resolving delirium in people with dementia.

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Key information

Conditions

Delirium Brain Diseases Central Nervous System Diseases Confusion Dementia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Crest Nursing Home, Bellefonte, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive stimulation

Behavioral

Thirty minutes of cognitive stimulation delivered daily for thirty minutes.

Primary outcomes

  1. Confusion Assessment Method

    Time frame: Averaged over 30 days or until discharge, whichever comes first

  2. Delirium Rating Scale

    Time frame: Averaged over 30 days or until discharge, whichever comes first

Secondary outcomes

  1. Attention

    Time frame: Averaged over 30 days or until discharge, whichever comes first

  2. Memory

    Time frame: Averaged over 30 days or until discharge, whichever comes first

  3. Abstract Thinking

    Time frame: Averaged over 30 days or until discharge, whichever comes first

  4. Orientation

    Time frame: Averaged over 30 days or until discharge, whichever comes first

  5. Executive Function

    Time frame: Averaged over 30 days or until discharge, whichever comes first

  6. Physical Function

    Time frame: Averaged over 30 days or until discharge, whichever comes first

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

Reserve For Delirium Superimposed On Dementia (DSD)

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Dec 28, 2010
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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