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Clinical Trials/NCT00388544
NCT00388544
Completed
Phase 2

A Prescription for Enhancing Resident Quality of Life

Penn State University1 site in 1 country128 target enrollmentMay 2005

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
Penn State University
Enrollment
128
Locations
1
Primary Endpoint
Agitation
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
February 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ann Kolanowski

Professor of Nursing

Penn State University

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.

Outcomes

Primary Outcomes

Agitation

Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period

Passivity

Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period

Secondary Outcomes

  • Mood(During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
  • Affect(During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
  • Engagement(During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)

Study Sites (1)

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