Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

October 13, 2006
May 8, 2012
May 2005
February 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Agitation
  • Passivity
Complete list of historical versions of study NCT00388544 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Mood
  • Affect
  • Engagement
Not Provided
Not Provided
 
Enhancing Quality of Life for Nursing Home Residents
A Prescription for Enhancing Resident Quality of Life

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Alzheimer's Disease
  • Behavioral: Activity matched to interest
    Recreational activities are tailored to subject's style of interest
  • Behavioral: Activity matched to function
    Recreational activities are tailored to subjects physical and cognitive functioning
  • Behavioral: Activity matched to both interest and function
    Recreational activities are tailored to both style of interest and physical and cognitive functioning.
  • Experimental: 1
    Intervention: Behavioral: Activity matched to interest
  • Experimental: 2
    Intervention: Behavioral: Activity matched to function
  • Experimental: 3
    Intervention: Behavioral: Activity matched to both interest and function
  • No Intervention: 4
    Recreational activities are not tailored to either style of interest or function

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00388544
19150, R01NR008910, R01 NR008910-01A1
Yes
Ann Kolanowski, Penn State University
Penn State University
National Institute of Nursing Research (NINR)
Principal Investigator: Ann Kolanowski, PhD, RN Penn State University
Penn State University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP