Enhancing Quality of Life for Nursing Home Residents
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| ClinicalTrials.gov Identifier: NCT00388544 |
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Recruitment Status :
Completed
First Posted : October 17, 2006
Last Update Posted : May 9, 2012
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Sponsor:
Penn State University
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Ann Kolanowski, Penn State University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Behavioral: Activity matched to interest Behavioral: Activity matched to function Behavioral: Activity matched to both interest and function | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 128 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Double (Care Provider, Outcomes Assessor) |
| Primary Purpose: | Diagnostic |
| Official Title: | A Prescription for Enhancing Resident Quality of Life |
| Study Start Date : | May 2005 |
| Actual Primary Completion Date : | February 2010 |
| Actual Study Completion Date : | February 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Alzheimer disease
| 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. |
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No Intervention: 4
Recreational activities are not tailored to either style of interest or function
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Primary Outcome Measures :
- 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 Outcome Measures :
- Mood [ Time Frame: 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 ]
- Engagement [ Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period ]
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388544
Locations
| United States, Pennsylvania | |
| Nursing homes in Central and Northeast Pennsylvania | |
| University Park, Pennsylvania, United States, 16802 | |
Sponsors and Collaborators
Penn State University
National Institute of Nursing Research (NINR)
Investigators
| Principal Investigator: | Ann Kolanowski, PhD, RN | Penn State University |
Publications of Results:
Other Publications:
Other Publications:
Buettner, L., Kolanowski, A. & Yu, F. (2007). Recreational games: Simple and effective cognitive stimulation programs for residents with dementia in long-term settings. American Journal of Recreation Therapy, 6 (1), 25-30.
Smith, M., Kolanowski, A., Buettner, S., & Buckwalter, K. (accepted). Beyond bingo and painted nails: Meaningful activities for persons with dementia in the nursing home. Annals of Long Term Care.
Haidet, K., Tate, J., Divirgilio-Thomas, D. Kolanowski, A., & Happ, MB. (accepted). Using video recording to capture behavioral observations in clinical research: Methods to improve reliability of data. Research in Nursing & Health.
| Responsible Party: | Ann Kolanowski, Professor of Nursing, Penn State University |
| ClinicalTrials.gov Identifier: | NCT00388544 |
| Other Study ID Numbers: |
19150 R01NR008910 ( U.S. NIH Grant/Contract ) R01NR008910-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 17, 2006 Key Record Dates |
| Last Update Posted: | May 9, 2012 |
| Last Verified: | May 2012 |
Additional relevant MeSH terms:
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |