Clinical trial NCT01267682: Cognitive Intervention For Delirium in Dementia
Official title: Reserve For Delirium Superimposed On Dementia (DSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delirium
Dementia
Keywords: Delirium
Dementia
Non-pharmacological Intervention
Post-acute care
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2010-12-28
Enrollment: 283
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

  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

Primary outcomes:
measure: Confusion Assessment Method
timeFrame: Averaged over 30 days or until discharge, whichever comes first
measure: Delirium Rating Scale
timeFrame: Averaged over 30 days or until discharge, whichever comes first
Secondary outcomes:
measure: Attention
timeFrame: Averaged over 30 days or until discharge, whichever comes first
measure: Memory
timeFrame: Averaged over 30 days or until discharge, whichever comes first
measure: Abstract Thinking
timeFrame: Averaged over 30 days or until discharge, whichever comes first
measure: Orientation
timeFrame: Averaged over 30 days or until discharge, whichever comes first
measure: Executive Function
timeFrame: Averaged over 30 days or until discharge, whichever comes first
measure: Physical Function
timeFrame: Averaged over 30 days or until discharge, whichever comes first
Other outcomes:
Locations:
city: Bellefonte
country: United States
facility: Centre Crest Nursing Home
state: Pennsylvania
city: Dallas
country: United States
facility: The Meadows Manor
state: Pennsylvania
city: Harrisburg
country: United States
facility: Spring Creek Rehabilitation and Nursing Center
state: Pennsylvania
city: Philipsburg
country: United States
facility: Windy Hill Village
state: Pennsylvania
city: Scranton
country: United States
facility: Mountain View
state: Pennsylvania
city: State College
country: United States
facility: Brookline Nursing & Rehabilitation Center
state: Pennsylvania
city: State College
country: United States
facility: Hearthside Nursing and Rehabilitation Center
state: Pennsylvania
city: State College
country: United States
facility: Hearthside Nursing Home
state: Pennsylvania
city: State College
country: United States
facility: The Village at Penn State
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Ann M Kolanowski, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Donna M Fick, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.