Cognitive Intervention For Delirium in Dementia

NCT01267682 | Completed Phase 2 DMC

• 1 other identifier: R01NR012242
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Delirium; Dementia

Keywords

Delirium; Dementia; Non-pharmacological Intervention; Post-acute care

Outcome Measures

Primary Outcomes (2)

• Confusion Assessment Method

  Averaged over 30 days or until discharge, whichever comes first

• Delirium Rating Scale

  Averaged over 30 days or until discharge, whichever comes first

Secondary Outcomes (6)

• Attention

  Averaged over 30 days or until discharge, whichever comes first

• Memory

  Averaged over 30 days or until discharge, whichever comes first

• Abstract Thinking

  Averaged over 30 days or until discharge, whichever comes first

• Orientation

  Averaged over 30 days or until discharge, whichever comes first

• Executive Function

  Averaged over 30 days or until discharge, whichever comes first

Study Arms (2)

Usual care

NO INTERVENTION

Participants receive standard clinical care

Treatment

EXPERIMENTAL

Behavioral: cognitive stimulation

Behavioral: Cognitive Stimulation

Interventions

Cognitive Stimulation BEHAVIORAL

Thirty minutes of cognitive stimulation delivered daily for thirty minutes.

Treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• presence of delirium
• mild to moderate cognitive impairments
• years of age or older
• English speaking
• community-dwelling
• legally authorized representative available

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

Study Sites (9)

Centre Crest Nursing Home

Bellefonte, Pennsylvania, 16823, United States

Location

The Meadows Manor

Dallas, Pennsylvania, 18612, United States

Location

Spring Creek Rehabilitation and Nursing Center

Harrisburg, Pennsylvania, 17111, United States

Location

Windy Hill Village

Philipsburg, Pennsylvania, 16866, United States

Location

Mountain View

Scranton, Pennsylvania, 18505, United States

Location

Brookline Nursing & Rehabilitation Center

State College, Pennsylvania, 16801, United States

Location

Hearthside Nursing and Rehabilitation Center

State College, Pennsylvania, 16801, United States

Location

Hearthside Nursing Home

State College, Pennsylvania, 16801, United States

Location

The Village at Penn State

State College, Pennsylvania, 16803, United States

Location

Related Publications (11)

• 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.

  PMID: 22513181 BACKGROUND

• 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.

  PMID: 21569370 BACKGROUND

• 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.

  PMID: 21053841 BACKGROUND

• 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.

  PMID: 20336555 BACKGROUND

• 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.

  PMID: 22904596 BACKGROUND

• 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.

  PMID: 23066682 BACKGROUND

• 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.

  PMID: 22652933 BACKGROUND

• 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.

  PMID: 23859475 BACKGROUND

• 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.

  PMID: 24121464 BACKGROUND

• 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.

  PMID: 24856271 RESULT

• 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.

  PMID: 24635006 RESULT

MeSH Terms

Conditions

Delirium; Dementia

Condition Hierarchy (Ancestors)

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

Study Officials

• Ann M Kolanowski, PhD, RN

  Penn State University

  PRINCIPAL INVESTIGATOR

• Donna M Fick, PhD, RN

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 28, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

US (9)