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Cognitive Intervention For Delirium in Dementia

Sponsor
Penn State University (Other)
Overall Status
Completed
CT.gov ID
NCT01267682
Collaborator
(none)
283
Enrollment
9
Locations
2
Arms
62
Duration (Months)
31.4
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Stimulation
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
283 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Reserve For Delirium Superimposed On Dementia (DSD)
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Usual care

Participants receive standard clinical care
Experimental: Treatment

Behavioral: cognitive stimulation

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

Outcome Measures

Primary Outcome Measures

  1. Confusion Assessment Method [Averaged over 30 days or until discharge, whichever comes first]

  2. Delirium Rating Scale [Averaged over 30 days or until discharge, whichever comes first]

Secondary Outcome Measures

  1. Attention [Averaged over 30 days or until discharge, whichever comes first]

  2. Memory [Averaged over 30 days or until discharge, whichever comes first]

  3. Abstract Thinking [Averaged over 30 days or until discharge, whichever comes first]

  4. Orientation [Averaged over 30 days or until discharge, whichever comes first]

  5. Executive Function [Averaged over 30 days or until discharge, whichever comes first]

  6. Physical Function [Averaged over 30 days or until discharge, whichever comes first]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Crest Nursing Home Bellefonte Pennsylvania United States 16823
2 The Meadows Manor Dallas Pennsylvania United States 18612
3 Spring Creek Rehabilitation and Nursing Center Harrisburg Pennsylvania United States 17111
4 Windy Hill Village Philipsburg Pennsylvania United States 16866
5 Mountain View Scranton Pennsylvania United States 18505
6 Brookline Nursing & Rehabilitation Center State College Pennsylvania United States 16801
7 Hearthside Nursing and Rehabilitation Center State College Pennsylvania United States 16801
8 Hearthside Nursing Home State College Pennsylvania United States 16801
9 The Village at Penn State State College Pennsylvania United States 16803

Sponsors and Collaborators

  • Penn State University

Investigators

  • Principal Investigator: Ann M Kolanowski, PhD, RN, Penn State University
  • Principal Investigator: Donna M Fick, PhD, RN, Penn State University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ann Kolanowski, Professor of Nursing, Penn State University
ClinicalTrials.gov Identifier:
NCT01267682
Other Study ID Numbers:
  • R01NR012242
First Posted:
Dec 28, 2010
Last Update Posted:
Sep 27, 2016
Last Verified:
Sep 1, 2016
Keywords provided by Ann Kolanowski, Professor of Nursing, Penn State University
Delirium
Dementia
Non-pharmacological Intervention
Post-acute care
Additional relevant MeSH terms:
Dementia
Delirium

Study Results

No Results Posted as of Sep 27, 2016