Cognitive Intervention For Delirium in Dementia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ann Kolanowski, Penn State University
ClinicalTrials.gov Identifier:
NCT01267682
First received: December 23, 2010
Last updated: December 5, 2014
Last verified: December 2014
  Purpose

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


Condition Intervention Phase
Delirium
Dementia
Behavioral: Cognitive Stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reserve For Delirium Superimposed On Dementia (DSD)

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Confusion Assessment Method [ Time Frame: Averaged over 30 days or until discharge, whichever comes first ] [ Designated as safety issue: No ]
  • Delirium Rating Scale [ Time Frame: Averaged over 30 days or until discharge, whichever comes first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Attention [ Time Frame: Averaged over 30 days or until discharge, whichever comes first ] [ Designated as safety issue: No ]
  • Memory [ Time Frame: Averaged over 30 days or until discharge, whichever comes first ] [ Designated as safety issue: No ]
  • Abstract Thinking [ Time Frame: Averaged over 30 days or until discharge, whichever comes first ] [ Designated as safety issue: No ]
  • Orientation [ Time Frame: Averaged over 30 days or until discharge, whichever comes first ] [ Designated as safety issue: No ]
  • Executive Function [ Time Frame: Averaged over 30 days or until discharge, whichever comes first ] [ Designated as safety issue: No ]
  • Physical Function [ Time Frame: Averaged over 30 days or until discharge, whichever comes first ] [ Designated as safety issue: No ]

Estimated Enrollment: 256
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
Participants receive standard clinical care
Experimental: Treatment
Behavioral: cognitive stimulation
Behavioral: Cognitive Stimulation
Thirty minutes of cognitive stimulation delivered daily for thirty minutes.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

    1. major depression
    2. Parkinson's with Lewy Body disease
    3. Huntington's disease
    4. normal pressure hydrocephalus
    5. seizure disorder
    6. subdural hematoma
    7. head trauma
    8. known structural brain abnormalities
    9. acute CVA/stroke
    10. acute psychiatric condition
  • life expectancy < 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267682

Locations
United States, Pennsylvania
Centre Crest Nursing Home
Bellefonte, Pennsylvania, United States, 16823
The Meadows Manor
Dallas, Pennsylvania, United States, 18612
Spring Creek Rehabilitation and Nursing Center
Harrisburg, Pennsylvania, United States, 17111
Windy Hill Village
Philipsburg, Pennsylvania, United States, 16866
Mountain View
Scranton, Pennsylvania, United States, 18505
Brookline Nursing & Rehabilitation Center
State College, Pennsylvania, United States, 16801
Hearthside Nursing and Rehabilitation Center
State College, Pennsylvania, United States, 16801
Hearthside Nursing Home
State College, Pennsylvania, United States, 16801
The Village at Penn State
State College, Pennsylvania, United States, 16803
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Ann M Kolanowski, PhD, RN Penn State University
Principal Investigator: Donna M Fick, PhD, RN Penn State University
  More Information

Publications:

Responsible Party: Ann Kolanowski, Professor of Nursing, Penn State University
ClinicalTrials.gov Identifier: NCT01267682     History of Changes
Other Study ID Numbers: R01NR012242
Study First Received: December 23, 2010
Last Updated: December 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Delirium
Dementia
Non-pharmacological Intervention
Post-acute care

Additional relevant MeSH terms:
Delirium
Dementia
Brain Diseases
Central Nervous System Diseases
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2015