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Enhancing Quality of Life for Nursing Home Residents
This study is currently recruiting participants.
Verified by National Institute of Nursing Research (NINR), September 2008
Sponsored by: National Institute of Nursing Research (NINR)
Information provided by: National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier: NCT00388544
  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 II

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease Dementia Nursing Homes
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Double Blind (Caregiver, Outcomes Assessor), Active Control, Single Group Assignment
Official Title: A Prescription for Enhancing Resident Quality of Life

Further study details as provided by National Institute of Nursing Research (NINR):

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 ]

Estimated Enrollment: 140
Study Start Date: May 2005
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Behavioral: Activity matched to interest
Recreational activities are tailored to subject's style of interest
2: Experimental Behavioral: Activity matched to function
Recreational activities are tailored to subjects physical and cognitive functioning
3: Experimental Behavioral: Activity matched to both interest and function
Recreational activities are tailored to both style of interest and physical and cognitive functioning.
4: No Intervention
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

Contacts
Contact: Ann Kolanowski, PhD, RN 814-863-9901 amk20@psu.edu

Locations
United States, Pennsylvania
Nursing homes in Central and Northeast Pennsylvania Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Ann Kolanowski, PhD, RN     814-863-9901     amk20@psu.edu    
Principal Investigator: Ann Kolanowski, PhD, RN            
Sponsors and Collaborators
Investigators
Principal Investigator: Ann Kolanowski, PhD, RN Pennsylvania State University
  More Information

Publications:
Responsible Party: Penn State University, School of Nursing ( Ann Kolanowski, PhD, RN )
Study ID Numbers: 19150, R01 NR008910-01A1
Study First Received: October 13, 2006
Last Updated: September 4, 2008
ClinicalTrials.gov Identifier: NCT00388544  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Quality of Life
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009