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Cognitive Intervention For Delirium in Dementia

Primary Purpose

Delirium, Dementia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive Stimulation
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring Delirium, Dementia, Non-pharmacological Intervention, Post-acute care

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Crest Nursing Home
  • The Meadows Manor
  • Spring Creek Rehabilitation and Nursing Center
  • Windy Hill Village
  • Mountain View
  • Brookline Nursing & Rehabilitation Center
  • Hearthside Nursing and Rehabilitation Center
  • Hearthside Nursing Home
  • The Village at Penn State

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Treatment

Arm Description

Participants receive standard clinical care

Behavioral: cognitive stimulation

Outcomes

Primary Outcome Measures

Confusion Assessment Method
Delirium Rating Scale

Secondary Outcome Measures

Attention
Memory
Abstract Thinking
Orientation
Executive Function
Physical Function

Full Information

First Posted
December 23, 2010
Last Updated
September 26, 2016
Sponsor
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT01267682
Brief Title
Cognitive Intervention For Delirium in Dementia
Official Title
Reserve For Delirium Superimposed On Dementia (DSD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Dementia
Keywords
Delirium, Dementia, Non-pharmacological Intervention, Post-acute care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
283 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants receive standard clinical care
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Behavioral: cognitive stimulation
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Stimulation
Intervention Description
Thirty minutes of cognitive stimulation delivered daily for thirty minutes.
Primary Outcome Measure Information:
Title
Confusion Assessment Method
Time Frame
Averaged over 30 days or until discharge, whichever comes first
Title
Delirium Rating Scale
Time Frame
Averaged over 30 days or until discharge, whichever comes first
Secondary Outcome Measure Information:
Title
Attention
Time Frame
Averaged over 30 days or until discharge, whichever comes first
Title
Memory
Time Frame
Averaged over 30 days or until discharge, whichever comes first
Title
Abstract Thinking
Time Frame
Averaged over 30 days or until discharge, whichever comes first
Title
Orientation
Time Frame
Averaged over 30 days or until discharge, whichever comes first
Title
Executive Function
Time Frame
Averaged over 30 days or until discharge, whichever comes first
Title
Physical Function
Time Frame
Averaged over 30 days or until discharge, whichever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 acute CVA/stroke acute psychiatric condition life expectancy < 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann M Kolanowski, PhD, RN
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donna M Fick, PhD, RN
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Crest Nursing Home
City
Bellefonte
State/Province
Pennsylvania
ZIP/Postal Code
16823
Country
United States
Facility Name
The Meadows Manor
City
Dallas
State/Province
Pennsylvania
ZIP/Postal Code
18612
Country
United States
Facility Name
Spring Creek Rehabilitation and Nursing Center
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17111
Country
United States
Facility Name
Windy Hill Village
City
Philipsburg
State/Province
Pennsylvania
ZIP/Postal Code
16866
Country
United States
Facility Name
Mountain View
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18505
Country
United States
Facility Name
Brookline Nursing & Rehabilitation Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Hearthside Nursing and Rehabilitation Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Hearthside Nursing Home
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
The Village at Penn State
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22513181
Citation
Yevchak A, Steis M, Diehl T, Hill N, Kolanowski A, Fick D. Managing delirium in the acute care setting: a pilot focus group study. Int J Older People Nurs. 2012 Jun;7(2):152-62. doi: 10.1111/j.1748-3743.2012.00324.x. Epub 2012 Apr 18.
Results Reference
background
PubMed Identifier
21569370
Citation
Kolanowski AM, Fick DM, Litaker MS, Clare L, Leslie D, Boustani M. Study protocol for the recreational stimulation for elders as a vehicle to resolve delirium superimposed on dementia (Reserve For DSD) trial. Trials. 2011 May 11;12:119. doi: 10.1186/1745-6215-12-119.
Results Reference
background
PubMed Identifier
21053841
Citation
Kolanowski AM, Fick DM, Clare L, Steis M, Boustani M, Litaker M. Pilot study of a nonpharmacological intervention for delirium superimposed on dementia. Res Gerontol Nurs. 2011 Jul;4(3):161-7. doi: 10.3928/19404921-20101001-98. Epub 2010 Oct 29.
Results Reference
background
PubMed Identifier
20336555
Citation
Kolanowski AM, Fick DM, Clare L, Therrien B, Gill DJ. An intervention for delirium superimposed on dementia based on cognitive reserve theory. Aging Ment Health. 2010 Mar;14(2):232-42. doi: 10.1080/13607860903167853.
Results Reference
background
PubMed Identifier
22904596
Citation
Hill NL, Kolanowski AM, Gill DJ. Plasticity in Early Alzheimer's Disease: An Opportunity for Intervention. Top Geriatr Rehabil. 2011 Oct;27(4):257-267. doi: 10.1097/tgr.0b013e31821e588e.
Results Reference
background
PubMed Identifier
23066682
Citation
Kolanowski AM, Fick DM, Yevchak AM, Hill NL, Mulhall PM, McDowell JA. Pay attention! The critical importance of assessing attention in older adults with dementia. J Gerontol Nurs. 2012 Nov;38(11):23-7. doi: 10.3928/00989134-20121003-05. Epub 2012 Oct 15.
Results Reference
background
PubMed Identifier
22652933
Citation
Kolanowski A, Bossen A, Hill N, Guzman-Velez E, Litaker M. Factors associated with sustained attention during an activity intervention in persons with dementia. Dement Geriatr Cogn Disord. 2012;33(4):233-9. doi: 10.1159/000338604. Epub 2012 May 31.
Results Reference
background
PubMed Identifier
23859475
Citation
Kolanowski A, Mulhall P, Yevchak A, Hill N, Fick D. The triple challenge of recruiting older adults with dementia and high medical acuity in skilled nursing facilities. J Nurs Scholarsh. 2013 Dec;45(4):397-404. doi: 10.1111/jnu.12042. Epub 2013 Jul 16.
Results Reference
background
PubMed Identifier
24121464
Citation
Yevchak AM, Fick DM, McDowell J, Monroe T, May K, Grove L, Kolanowski AM, Waller JL, Inouye SK. Barriers and facilitators to implementing delirium rounds in a clinical trial across three diverse hospital settings. Clin Nurs Res. 2014 Apr;23(2):201-15. doi: 10.1177/1054773813505321. Epub 2013 Oct 11.
Results Reference
background
PubMed Identifier
24856271
Citation
Kolanowski AM, Hill NL, Kurum E, Fick DM, Yevchak AM, Mulhall P, Clare L, Valenzuela M. Gender differences in factors associated with delirium severity in older adults with dementia. Arch Psychiatr Nurs. 2014 Jun;28(3):187-92. doi: 10.1016/j.apnu.2014.01.004. Epub 2014 Feb 5.
Results Reference
result
PubMed Identifier
24635006
Citation
Hill NL, Kolanowski AM, Fick D, Chinchilli VM, Jablonski RA. Personality as a moderator of cognitive stimulation in older adults at high risk for cognitive decline. Res Gerontol Nurs. 2014 Jul-Aug;7(4):159-70. doi: 10.3928/19404921-20140311-01. Epub 2014 Mar 18.
Results Reference
result

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Cognitive Intervention For Delirium in Dementia

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