Enhancing Quality of Life for Nursing Home Residents

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Behavioral: Activity matched to interest; Behavioral: Activity matched to function; Behavioral: Activity matched to both interest and function

• Registration Number: NCT00388544
• Lead Sponsor: Penn State University

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-10-13
• Study First Submitted QC: 2006-10-13
• Study First Posted: 2006-10-17
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-08
• Last Update Posted: 2012-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Activity matched to interest	-
2	Activity matched to function	-
3	Activity matched to both interest and function	-

Primary Outcome Measures

Name	Time	Method
Agitation	During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period
Passivity	During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nursing homes in Central and Northeast Pennsylvania; 🇺🇸 University Park, Pennsylvania, United States