Enhancing Quality of Life for Nursing Home Residents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ann Kolanowski, Penn State University
ClinicalTrials.gov Identifier:
NCT00388544
First received: October 13, 2006
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Behavioral: Activity matched to interest
Behavioral: Activity matched to function
Behavioral: Activity matched to both interest and function
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Prescription for Enhancing Resident Quality of Life

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Agitation [ Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period ] [ Designated as safety issue: No ]
  • Passivity [ Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mood [ Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period ] [ Designated as safety issue: No ]
  • Affect [ Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period ] [ Designated as safety issue: No ]
  • Engagement [ Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: May 2005
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Activity matched to interest
Recreational activities are tailored to subject's style of interest
Experimental: 2 Behavioral: Activity matched to function
Recreational activities are tailored to subjects physical and cognitive functioning
Experimental: 3 Behavioral: Activity matched to both interest and function
Recreational activities are tailored to both style of interest and physical and cognitive functioning.
No Intervention: 4
Recreational activities are not tailored to either style of interest or function

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388544

Locations
United States, Pennsylvania
Nursing homes in Central and Northeast Pennsylvania
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Ann Kolanowski, PhD, RN Penn State University
  More Information

Publications:
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.
Whall, A., Colling, K., Kolanowski, A., Kim, H., Son Hong, G., DeCicco, B., Ronis, D., Richards, K., Algase, D., Beck, C. (2008). Factors associated with aggressive behavior among nursing home residents with dementia. The Gerontologist 48, 721-731.
Dettmore, D., Kolanowski, A. & Boustani, M. (2009). Aggression in persons with dementia: Use of nursing theory to guide practice. Geriatric Nursing, 30 (1), 8-17
Kolanowski, A., Fick, D., Campbell, J., Litaker, M., & Boustani, M. (2009). A preliminary study of anticholinergic burden and relationship to a quality of life indicator, engagement in activities, in nursing home residents with dementia. Journal of the American Medical Director's Association, 10 (4), 252-257.

Responsible Party: Ann Kolanowski, Professor of Nursing, Penn State University
ClinicalTrials.gov Identifier: NCT00388544     History of Changes
Other Study ID Numbers: 19150, R01NR008910, R01 NR008910-01A1
Study First Received: October 13, 2006
Last Updated: May 8, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 14, 2014