Cognitive Intervention For Delirium in Dementia

September 26, 2016 updated by: Ann Kolanowski, Penn State University

Reserve For Delirium Superimposed On Dementia (DSD)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

283

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bellefonte, Pennsylvania, United States, 16823
        • Centre Crest Nursing Home
      • Dallas, Pennsylvania, United States, 18612
        • The Meadows Manor
      • Harrisburg, Pennsylvania, United States, 17111
        • Spring Creek Rehabilitation and Nursing Center
      • Philipsburg, Pennsylvania, United States, 16866
        • Windy Hill Village
      • Scranton, Pennsylvania, United States, 18505
        • Mountain View
      • State College, Pennsylvania, United States, 16801
        • 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, 16803
        • The Village at Penn State

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Confusion Assessment Method
Time Frame: Averaged over 30 days or until discharge, whichever comes first
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
Averaged over 30 days or until discharge, whichever comes first

Secondary Outcome Measures

Outcome Measure
Time Frame
Attention
Time Frame: Averaged over 30 days or until discharge, whichever comes first
Averaged over 30 days or until discharge, whichever comes first
Memory
Time Frame: Averaged over 30 days or until discharge, whichever comes first
Averaged over 30 days or until discharge, whichever comes first
Abstract Thinking
Time Frame: Averaged over 30 days or until discharge, whichever comes first
Averaged over 30 days or until discharge, whichever comes first
Orientation
Time Frame: Averaged over 30 days or until discharge, whichever comes first
Averaged over 30 days or until discharge, whichever comes first
Executive Function
Time Frame: Averaged over 30 days or until discharge, whichever comes first
Averaged over 30 days or until discharge, whichever comes first
Physical Function
Time Frame: Averaged over 30 days or until discharge, whichever comes first
Averaged over 30 days or until discharge, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Investigators

  • Principal Investigator: Ann M Kolanowski, PhD, RN, Penn State University
  • Principal Investigator: Donna M Fick, PhD, RN, Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 23, 2010

First Submitted That Met QC Criteria

December 27, 2010

First Posted (Estimate)

December 28, 2010

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NR012242 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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