Enhancing Quality of Life for Nursing Home Residents

May 8, 2012 updated by: Ann Kolanowski, Penn State University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Nursing homes in Central and Northeast Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Ann Kolanowski, PhD, RN, Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 13, 2006

First Submitted That Met QC Criteria

October 13, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)

May 9, 2012

Last Update Submitted That Met QC Criteria

May 8, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19150
  • R01NR008910 (U.S. NIH Grant/Contract)
  • R01NR008910-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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