| October 13, 2006 |
| May 8, 2012 |
| May 2005 |
| February 2010 (final data collection date for primary outcome measure) |
- Agitation [ Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period ] [ Designated as safety issue: No ]
- Passivity [ Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period ] [ Designated as safety issue: No ]
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| Complete list of historical versions of study NCT00388544 on ClinicalTrials.gov Archive Site |
- Mood [ Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period ] [ Designated as safety issue: No ]
- Affect [ Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period ] [ Designated as safety issue: No ]
- Engagement [ Time Frame: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period ] [ Designated as safety issue: No ]
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| Not Provided |
| Not Provided |
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| Enhancing Quality of Life for Nursing Home Residents |
| 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. |
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. |
| Interventional |
| Phase 2 |
Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Caregiver, Outcomes Assessor) Primary Purpose: Diagnostic |
| Alzheimer's Disease |
- Behavioral: Activity matched to interest
Recreational activities are tailored to subject's style of interest
- Behavioral: Activity matched to function
Recreational activities are tailored to subjects physical and cognitive functioning
- 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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- Experimental: 1
Intervention: Behavioral: Activity matched to interest
- Experimental: 2
Intervention: Behavioral: Activity matched to function
- Experimental: 3
Intervention: Behavioral: Activity matched to both interest and function
- No Intervention: 4
Recreational activities are not tailored to either style of interest or function
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- Kolanowski A, Litaker M, Buettner L, Moeller J, Costa PT Jr. A randomized clinical trial of theory-based activities for the behavioral symptoms of dementia in nursing home residents. J Am Geriatr Soc. 2011 Jun;59(6):1032-41. Epub 2011 Jun 7.
- Fick DM, Kolanowski AM, Waller JL, Inouye SK. Delirium superimposed on dementia in a community-dwelling managed care population: a 3-year retrospective study of occurrence, costs, and utilization. J Gerontol A Biol Sci Med Sci. 2005 Jun;60(6):748-53.
- Kolanowski AM, Litaker M, Buettner L. Efficacy of theory-based activities for behavioral symptoms of dementia. Nurs Res. 2005 Jul-Aug;54(4):219-28.
- Kolanowski A, Litaker M. Social interaction, premorbid personality, and agitation in nursing home residents with dementia. Arch Psychiatr Nurs. 2006 Feb;20(1):12-20.
- Kolanowski A, Buettner L, Litaker M, Yu F. Factors that relate to activity engagement in nursing home residents. Am J Alzheimers Dis Other Demen. 2006 Jan-Feb;21(1):15-22.
- Kolanowski A, Fick D, Waller JL, Ahern F. Outcomes of antipsychotic drug use in community-dwelling elders with dementia. Arch Psychiatr Nurs. 2006 Oct;20(5):217-25.
- Yu F, Kolanowski AM, Litaker M. The association of physical function with agitation and passivity in nursing home residents with dementia. J Gerontol Nurs. 2006 Dec;32(12):30-6.
- Woods CA. Working better with GPs: lessons to be learned from a study of health care networks in the management of diabetes. Clin Exp Optom. 2006 Jan;89(1):1-2. No abstract available.
- Kolanowski A, Buettner L, Moeller J. Treatment fidelity plan for an activity intervention designed for persons with dementia. Am J Alzheimers Dis Other Demen. 2006 Oct-Nov;21(5):326-32.
- Penrod J, Yu F, Kolanowski A, Fick DM, Loeb SJ, Hupcey JE. Reframing person-centered nursing care for persons with dementia. Res Theory Nurs Pract. 2007;21(1):57-72. Review.
- Kolanowski A, Hoffman L, Hofer SM. Concordance of self-report and informant assessment of emotional well-being in nursing home residents with dementia. J Gerontol B Psychol Sci Soc Sci. 2007 Jan;62(1):P20-7.
- 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.
- Kolanowski A, Buettner L. Prescribing activities that engage passive residents. An innovative method. J Gerontol Nurs. 2008 Jan;34(1):13-8.
- Whall, A., Colling, K., Kolanowski, A., Kim, H., Son Hong, G., DeCicco, B., Ronis, D., Richards, K., Algase, D., Beck, C. (2008). Factors associated with aggressive behavior among nursing home residents with dementia. The Gerontologist 48, 721-731.
- Dettmore, D., Kolanowski, A. & Boustani, M. (2009). Aggression in persons with dementia: Use of nursing theory to guide practice. Geriatric Nursing, 30 (1), 8-17
- Kolanowski, A., Fick, D., Campbell, J., Litaker, M., & Boustani, M. (2009). A preliminary study of anticholinergic burden and relationship to a quality of life indicator, engagement in activities, in nursing home residents with dementia. Journal of the American Medical Director's Association, 10 (4), 252-257.
- Haidet KK, Tate J, Divirgilio-Thomas D, Kolanowski A, Happ MB. Methods to improve reliability of video-recorded behavioral data. Res Nurs Health. 2009 Aug;32(4):465-74. Review.
- Lingler JH, Jablonski RA, Bourbonniere M, Kolanowski A. Informed consent to research in long-term care settings. Res Gerontol Nurs. 2009 Jul;2(3):153-61. Epub 2009 May 29.
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| Completed |
| 128 |
| February 2010 |
| February 2010 (final data collection date for primary outcome measure) |
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.
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| Both |
| 65 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00388544 |
| 19150, R01NR008910, R01 NR008910-01A1 |
| Yes |
| Ann Kolanowski, Penn State University |
| Penn State University |
| National Institute of Nursing Research (NINR) |
| Principal Investigator: |
Ann Kolanowski, PhD, RN |
Penn State University |
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| Penn State University |
| May 2012 |