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DeliriumPhase 2NCT01267682

Cognitive Intervention For Delirium in Dementia

A Phase 2 study testing Cognitive Stimulation in people with Delirium and Dementia, run by Penn State University at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 65 years and older
Conditions the study is for
Delirium, Dementia
What is being tested?
Cognitive Stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
283 participants
Where
9 sitesUnited States
Study dates
Jan 2011to Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • severe vision or hearing problems
  • diagnosis of
  • major depression
  • Parkinson's with Lewy Body disease
  • Huntington's disease
  • normal pressure hydrocephalus
Show all 13Show fewer
  • seizure disorder
  • subdural hematoma
  • head trauma
  • known structural brain abnormalities
  • acute CVA/stroke
  • acute psychiatric condition
  • life expectancy < 6 months

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Centre Crest Nursing Home

    Bellefonte, Pennsylvania, 16823

  • The Meadows Manor

    Dallas, Pennsylvania, 18612

  • Spring Creek Rehabilitation and Nursing Center

    Harrisburg, Pennsylvania, 17111

  • Windy Hill Village

    Philipsburg, Pennsylvania, 16866

  • Mountain View

    Scranton, Pennsylvania, 18505

  • Brookline Nursing & Rehabilitation Center

    State College, Pennsylvania, 16801

  • Hearthside Nursing and Rehabilitation Center

    State College, Pennsylvania, 16801

  • Hearthside Nursing Home

    State College, Pennsylvania, 16801

  • The Village at Penn State

    State College, Pennsylvania, 16803

Other trials in United States

About this study

Official title: Reserve For Delirium Superimposed On Dementia (DSD)

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

Read the 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.

Conditions
Delirium, Dementia
Being tested
Cognitive Stimulation
Keywords
Delirium, Dementia, Non-pharmacological Intervention, Post-acute care
Medical subject headings
Delirium, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive StimulationBehavioural

    Thirty minutes of cognitive stimulation delivered daily for thirty minutes.

Study groups in NCT01267682
Study groupRoleWhat they receive
Usual careNo interventionParticipants receive standard clinical care
TreatmentExperimentalBehavioral: cognitive stimulation
Receives: Behavioral: Cognitive Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confusion Assessment Method

    Measured: Averaged over 30 days or until discharge, whichever comes first

  2. Delirium Rating Scale

    Measured: Averaged over 30 days or until discharge, whichever comes first

Secondary outcomes (6)

  1. Attention

    Measured: Averaged over 30 days or until discharge, whichever comes first

  2. Memory

    Measured: Averaged over 30 days or until discharge, whichever comes first

  3. Abstract Thinking

    Measured: Averaged over 30 days or until discharge, whichever comes first

  4. Orientation

    Measured: Averaged over 30 days or until discharge, whichever comes first

  5. Executive Function

    Measured: Averaged over 30 days or until discharge, whichever comes first

  6. Physical Function

    Measured: Averaged over 30 days or until discharge, whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
283 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01267682
Sponsor's protocol ID
R01NR012242
Status last verified
Sep 2016
First submitted
23 Dec 2010
Last updated
27 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22513181

  • 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.

    PubMed 21569370

  • 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.

    PubMed 21053841

  • 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.

    PubMed 20336555

  • 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.

    PubMed 22904596

  • 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.

    PubMed 23066682

  • 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.

    PubMed 22652933

  • 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.

    PubMed 23859475

  • 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.

    PubMed 24121464

  • 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.

    PubMed 24856271

  • 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.

    PubMed 24635006

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cognitive Stimulation in people with Delirium and Dementia, run by Penn State University at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confusion Assessment Method (time frame: Averaged over 30 days or until discharge, whichever comes first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01267682, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016; AzTrials last refreshed its copy on 30 Oct 2026.

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