Cognitive Intervention For Delirium in Dementia

NCT ID: NCT01267682

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Delirium Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual care

Participants receive standard clinical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment

Behavioral: cognitive stimulation

Group Type EXPERIMENTAL

Cognitive Stimulation

Intervention Type BEHAVIORAL

Thirty minutes of cognitive stimulation delivered daily for thirty minutes.

Interventions

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Cognitive Stimulation

Thirty minutes of cognitive stimulation delivered daily for thirty minutes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Ann Kolanowski

Professor of Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann M Kolanowski, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Donna M Fick, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

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Centre Crest Nursing Home

Bellefonte, Pennsylvania, United States

Site Status

The Meadows Manor

Dallas, Pennsylvania, United States

Site Status

Spring Creek Rehabilitation and Nursing Center

Harrisburg, Pennsylvania, United States

Site Status

Windy Hill Village

Philipsburg, Pennsylvania, United States

Site Status

Mountain View

Scranton, Pennsylvania, United States

Site Status

Brookline Nursing & Rehabilitation Center

State College, Pennsylvania, United States

Site Status

Hearthside Nursing and Rehabilitation Center

State College, Pennsylvania, United States

Site Status

Hearthside Nursing Home

State College, Pennsylvania, United States

Site Status

The Village at Penn State

State College, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22513181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21569370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21053841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20336555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22904596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23066682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22652933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23859475 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24121464 (View on PubMed)

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.

Reference Type RESULT
PMID: 24856271 (View on PubMed)

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.

Reference Type RESULT
PMID: 24635006 (View on PubMed)

Other Identifiers

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R01NR012242

Identifier Type: NIH

Identifier Source: org_study_id

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