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Completed

NCT Number: NCT00388544

Enhancing Quality of Life for Nursing Home Residents

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nursing homes in Central and Northeast Pennsylvania

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Activity matched to interest

Behavioral

Recreational activities are tailored to subject's style of interest

Activity matched to function

Behavioral

Recreational activities are tailored to subjects physical and cognitive functioning

Activity matched to both interest and function

Behavioral

Recreational activities are tailored to both style of interest and physical and cognitive functioning.

Primary outcomes

  1. Agitation

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

  2. Passivity

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

Secondary outcomes

  1. Mood

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

  2. Affect

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

  3. Engagement

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

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

A Prescription for Enhancing Resident Quality of Life

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Oct 17, 2006
Registry last updated
May 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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