Enhancing Quality of Life for Nursing Home Residents

Alzheimer's Disease Clinical Trial

Official title:

A Prescription for Enhancing Resident Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388544
• Other study ID #: 19150
• Secondary ID: R01NR008910R01NR
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2006
• Last updated: May 8, 2012
• Start date: May 2005
• Est. completion date: February 2010

Study information

• Verified date: May 2012
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• Activity matched to interest
Recreational activities are tailored to subject's style of interest
• Activity matched to function
Recreational activities are tailored to subjects physical and cognitive functioning
• Activity matched to both interest and function
Recreational activities are tailored to both style of interest and physical and cognitive functioning.

Locations

Country	Name	City	State
United States	Nursing homes in Central and Northeast Pennsylvania	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (19)

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.

Dettmore D, Kolanowski A, Boustani M. Aggression in persons with dementia: use of nursing theory to guide clinical practice. Geriatr Nurs. 2009 Jan-Feb;30(1):8-17. doi: 10.1016/j.gerinurse.2008.03.001. — View Citation

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. — View Citation

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. doi: 10.1002/nur.20334. Review. — View Citation

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. — View Citation

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. — View Citation

Kolanowski A, Buettner L. Prescribing activities that engage passive residents. An innovative method. J Gerontol Nurs. 2008 Jan;34(1):13-8. — View Citation

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. — View Citation

Kolanowski A, Fick DM, Campbell J, Litaker M, Boustani M. A preliminary study of anticholinergic burden and relationship to a quality of life indicator, engagement in activities, in nursing home residents with dementia. J Am Med Dir Assoc. 2009 May;10(4):252-7. doi: 10.1016/j.jamda.2008.11.005. Epub 2009 Jan 9. — View Citation

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. — View Citation

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. doi: 10.1111/j.1532-5415.2011. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.3928/19404921-20090428-03. Epub 2009 May 29. — View Citation

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. — View Citation

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.

Whall AL, Colling KB, Kolanowski A, Kim H, Son Hong GR, DeCicco B, Ronis DL, Richards KC, Algase D, Beck C. Factors associated with aggressive behavior among nursing home residents with dementia. Gerontologist. 2008 Dec;48(6):721-31. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agitation		During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period	No
Primary	Passivity		During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period	No
Secondary	Mood		During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period	No
Secondary	Affect		During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period	No
Secondary	Engagement		During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period	No