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Enhancing Quality of Life for Nursing Home Residents

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Activity matched to interest
Activity matched to function
Activity matched to both interest and function
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English speaking; diagnosis of dementia; a willing informant who knows the subject well and who can provide past personality and other data; a stable dose of any psychoactive drug from pre-baseline through final observation; and presence of agitation or passivity.

Exclusion Criteria:

  • delirium or an unstable medical condition; history of Parkinson's disease, Huntington's disease, seizure disorder, stroke, alcoholism, drug abuse, head trauma with loss of consciousness, or psychiatric illness preceding the onset of memory loss; severe vision or hearing impairment; and receiving a new psychoactive medication within the past 30 days.

Sites / Locations

  • Nursing homes in Central and Northeast Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

1

2

3

4

Arm Description

Recreational activities are not tailored to either style of interest or function

Outcomes

Primary Outcome Measures

Agitation
Passivity

Secondary Outcome Measures

Mood
Affect
Engagement

Full Information

First Posted
October 13, 2006
Last Updated
May 8, 2012
Sponsor
Penn State University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00388544
Brief Title
Enhancing Quality of Life for Nursing Home Residents
Official Title
A Prescription for Enhancing Resident Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Many persons with dementia exhibit behaviors that caregivers find difficult to manage. The purpose of this study is to test the effectiveness of individualized recreational activities for reducing agitation and passivity in persons with dementia.
Detailed Description
Most persons with dementia exhibit behavioral symptoms, such as agitation and passivity, at some time in the course of their illness. These behaviors are a source of caregiver burden and often precipitate nursing home placement. There are a number of drugs that can be used to treat these behaviors, but they are costly and have serious adverse effects in a sizable number of people. Non-drug interventions, such as recreational activities, are recommended as the first line of treatment for behavioral symptoms. However, we don't know which activities are most effective for individual residents. The "one size fits all" approach has not been very effective. We are testing an approach that individualizes activities for residents based on their personality style of interest and functional level. We anticipate that this approach will be more effective for reducing behavioral symptoms than routine activities given to all residents. Consenting residents are assessed for personality and functional level and are videotaped during a baseline period and during activities so we can reliably measure behaviors, affect and engagement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
No Intervention
Arm Description
Recreational activities are not tailored to either style of interest or function
Intervention Type
Behavioral
Intervention Name(s)
Activity matched to interest
Intervention Description
Recreational activities are tailored to subject's style of interest
Intervention Type
Behavioral
Intervention Name(s)
Activity matched to function
Intervention Description
Recreational activities are tailored to subjects physical and cognitive functioning
Intervention Type
Behavioral
Intervention Name(s)
Activity matched to both interest and function
Intervention Description
Recreational activities are tailored to both style of interest and physical and cognitive functioning.
Primary Outcome Measure Information:
Title
Agitation
Time Frame
During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period
Title
Passivity
Time Frame
During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period
Secondary Outcome Measure Information:
Title
Mood
Time Frame
During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period
Title
Affect
Time Frame
During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period
Title
Engagement
Time Frame
During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking; diagnosis of dementia; a willing informant who knows the subject well and who can provide past personality and other data; a stable dose of any psychoactive drug from pre-baseline through final observation; and presence of agitation or passivity. Exclusion Criteria: delirium or an unstable medical condition; history of Parkinson's disease, Huntington's disease, seizure disorder, stroke, alcoholism, drug abuse, head trauma with loss of consciousness, or psychiatric illness preceding the onset of memory loss; severe vision or hearing impairment; and receiving a new psychoactive medication within the past 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Kolanowski, PhD, RN
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nursing homes in Central and Northeast Pennsylvania
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15983178
Citation
Fick DM, Kolanowski AM, Waller JL, Inouye SK. Delirium superimposed on dementia in a community-dwelling managed care population: a 3-year retrospective study of occurrence, costs, and utilization. J Gerontol A Biol Sci Med Sci. 2005 Jun;60(6):748-53. doi: 10.1093/gerona/60.6.748.
Results Reference
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PubMed Identifier
16027564
Citation
Kolanowski AM, Litaker M, Buettner L. Efficacy of theory-based activities for behavioral symptoms of dementia. Nurs Res. 2005 Jul-Aug;54(4):219-28. doi: 10.1097/00006199-200507000-00003.
Results Reference
background
PubMed Identifier
16442470
Citation
Kolanowski A, Litaker M. Social interaction, premorbid personality, and agitation in nursing home residents with dementia. Arch Psychiatr Nurs. 2006 Feb;20(1):12-20. doi: 10.1016/j.apnu.2005.08.006.
Results Reference
background
PubMed Identifier
16526585
Citation
Kolanowski A, Buettner L, Litaker M, Yu F. Factors that relate to activity engagement in nursing home residents. Am J Alzheimers Dis Other Demen. 2006 Jan-Feb;21(1):15-22. doi: 10.1177/153331750602100109.
Results Reference
background
PubMed Identifier
17010825
Citation
Kolanowski A, Fick D, Waller JL, Ahern F. Outcomes of antipsychotic drug use in community-dwelling elders with dementia. Arch Psychiatr Nurs. 2006 Oct;20(5):217-25. doi: 10.1016/j.apnu.2006.04.004.
Results Reference
background
PubMed Identifier
17190404
Citation
Yu F, Kolanowski AM, Litaker M. The association of physical function with agitation and passivity in nursing home residents with dementia. J Gerontol Nurs. 2006 Dec;32(12):30-6. doi: 10.3928/00989134-20061201-05.
Results Reference
background
PubMed Identifier
16430433
Citation
Woods CA. Working better with GPs: lessons to be learned from a study of health care networks in the management of diabetes. Clin Exp Optom. 2006 Jan;89(1):1-2. doi: 10.1111/j.1444-0938.2006.00006.x. No abstract available.
Results Reference
background
PubMed Identifier
17062551
Citation
Kolanowski A, Buettner L, Moeller J. Treatment fidelity plan for an activity intervention designed for persons with dementia. Am J Alzheimers Dis Other Demen. 2006 Oct-Nov;21(5):326-32. doi: 10.1177/1533317506291074.
Results Reference
background
PubMed Identifier
17378465
Citation
Penrod J, Yu F, Kolanowski A, Fick DM, Loeb SJ, Hupcey JE. Reframing person-centered nursing care for persons with dementia. Res Theory Nurs Pract. 2007;21(1):57-72. doi: 10.1891/rtnpij-v21i1a007.
Results Reference
background
PubMed Identifier
17284553
Citation
Kolanowski A, Hoffman L, Hofer SM. Concordance of self-report and informant assessment of emotional well-being in nursing home residents with dementia. J Gerontol B Psychol Sci Soc Sci. 2007 Jan;62(1):P20-7. doi: 10.1093/geronb/62.1.p20.
Results Reference
background
Citation
Buettner, L., Kolanowski, A. & Yu, F. (2007). Recreational games: Simple and effective cognitive stimulation programs for residents with dementia in long-term settings. American Journal of Recreation Therapy, 6 (1), 25-30.
Results Reference
background
PubMed Identifier
18274300
Citation
Kolanowski A, Buettner L. Prescribing activities that engage passive residents. An innovative method. J Gerontol Nurs. 2008 Jan;34(1):13-8. doi: 10.3928/00989134-20080101-08.
Results Reference
background
PubMed Identifier
19139246
Citation
Whall AL, Colling KB, Kolanowski A, Kim H, Son Hong GR, DeCicco B, Ronis DL, Richards KC, Algase D, Beck C. Factors associated with aggressive behavior among nursing home residents with dementia. Gerontologist. 2008 Dec;48(6):721-31. doi: 10.1093/geront/48.6.721.
Results Reference
background
PubMed Identifier
19215808
Citation
Dettmore D, Kolanowski A, Boustani M. Aggression in persons with dementia: use of nursing theory to guide clinical practice. Geriatr Nurs. 2009 Jan-Feb;30(1):8-17. doi: 10.1016/j.gerinurse.2008.03.001.
Results Reference
background
Citation
Smith, M., Kolanowski, A., Buettner, S., & Buckwalter, K. (accepted). Beyond bingo and painted nails: Meaningful activities for persons with dementia in the nursing home. Annals of Long Term Care.
Results Reference
background
PubMed Identifier
19426941
Citation
Kolanowski A, Fick DM, Campbell J, Litaker M, Boustani M. A preliminary study of anticholinergic burden and relationship to a quality of life indicator, engagement in activities, in nursing home residents with dementia. J Am Med Dir Assoc. 2009 May;10(4):252-7. doi: 10.1016/j.jamda.2008.11.005. Epub 2009 Jan 9.
Results Reference
background
PubMed Identifier
19434651
Citation
Haidet KK, Tate J, Divirgilio-Thomas D, Kolanowski A, Happ MB. Methods to improve reliability of video-recorded behavioral data. Res Nurs Health. 2009 Aug;32(4):465-74. doi: 10.1002/nur.20334.
Results Reference
background
PubMed Identifier
20078005
Citation
Lingler JH, Jablonski RA, Bourbonniere M, Kolanowski A. Informed consent to research in long-term care settings. Res Gerontol Nurs. 2009 Jul;2(3):153-61. doi: 10.3928/19404921-20090428-03. Epub 2009 May 29.
Results Reference
background
PubMed Identifier
21649633
Citation
Kolanowski A, Litaker M, Buettner L, Moeller J, Costa PT Jr. A randomized clinical trial of theory-based activities for the behavioral symptoms of dementia in nursing home residents. J Am Geriatr Soc. 2011 Jun;59(6):1032-41. doi: 10.1111/j.1532-5415.2011.03449.x. Epub 2011 Jun 7.
Results Reference
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Enhancing Quality of Life for Nursing Home Residents

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