Cognitive Intervention For Delirium in Dementia

Dementia Clinical Trial

Official title:

Reserve For Delirium Superimposed On Dementia (DSD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267682
• Other study ID #: R01NR012242
• Status: Completed
• Phase: Phase 2
• First received: December 23, 2010
• Last updated: September 26, 2016
• Start date: January 2011
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delirium
• Dementia

Intervention

Behavioral:
• Cognitive Stimulation
Thirty minutes of cognitive stimulation delivered daily for thirty minutes.

Locations

Country	Name	City	State
United States	Centre Crest Nursing Home	Bellefonte	Pennsylvania
United States	The Meadows Manor	Dallas	Pennsylvania
United States	Spring Creek Rehabilitation and Nursing Center	Harrisburg	Pennsylvania
United States	Windy Hill Village	Philipsburg	Pennsylvania
United States	Mountain View	Scranton	Pennsylvania
United States	Brookline Nursing & Rehabilitation Center	State College	Pennsylvania
United States	Hearthside Nursing and Rehabilitation Center	State College	Pennsylvania
United States	Hearthside Nursing Home	State College	Pennsylvania
United States	The Village at Penn State	State College	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (11)

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 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confusion Assessment Method		Averaged over 30 days or until discharge, whichever comes first	No
Primary	Delirium Rating Scale		Averaged over 30 days or until discharge, whichever comes first	No
Secondary	Attention		Averaged over 30 days or until discharge, whichever comes first	No
Secondary	Memory		Averaged over 30 days or until discharge, whichever comes first	No
Secondary	Abstract Thinking		Averaged over 30 days or until discharge, whichever comes first	No
Secondary	Orientation		Averaged over 30 days or until discharge, whichever comes first	No
Secondary	Executive Function		Averaged over 30 days or until discharge, whichever comes first	No
Secondary	Physical Function		Averaged over 30 days or until discharge, whichever comes first	No