Enhancing Quality of Life for Nursing Home Residents

NCT00388544 | Completed Phase 2 DMC

• 3 other identifiers: 19150R01NR008910R01NR008910-01A1
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (4)

1

EXPERIMENTAL

Behavioral: Activity matched to interest

2

EXPERIMENTAL

Behavioral: Activity matched to function

3

EXPERIMENTAL

Behavioral: Activity matched to both interest and function

4

NO INTERVENTION

Recreational activities are not tailored to either style of interest or function

Interventions

Activity matched to interest BEHAVIORAL

Recreational activities are tailored to subject's style of interest

1

Activity matched to function BEHAVIORAL

Recreational activities are tailored to subjects physical and cognitive functioning

2

Activity matched to both interest and function BEHAVIORAL

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

3

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penn State University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Nursing homes in Central and Northeast Pennsylvania

University Park, Pennsylvania, 16802, United States

Location

Related Publications (19)

• 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. doi: 10.1093/gerona/60.6.748.

  PMID: 15983178 BACKGROUND

• 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. doi: 10.1097/00006199-200507000-00003.

  PMID: 16027564 BACKGROUND

• 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. doi: 10.1016/j.apnu.2005.08.006.

  PMID: 16442470 BACKGROUND

• 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. doi: 10.1177/153331750602100109.

  PMID: 16526585 BACKGROUND

• 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. doi: 10.1016/j.apnu.2006.04.004.

  PMID: 17010825 BACKGROUND

• 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. doi: 10.3928/00989134-20061201-05.

  PMID: 17190404 BACKGROUND

• 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. doi: 10.1111/j.1444-0938.2006.00006.x. No abstract available.

  PMID: 16430433 BACKGROUND

• 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. doi: 10.1177/1533317506291074.

  PMID: 17062551 BACKGROUND

• 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. doi: 10.1891/rtnpij-v21i1a007.

  PMID: 17378465 BACKGROUND

• 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. doi: 10.1093/geronb/62.1.p20.

  PMID: 17284553 BACKGROUND

• 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.

  BACKGROUND

• Kolanowski A, Buettner L. Prescribing activities that engage passive residents. An innovative method. J Gerontol Nurs. 2008 Jan;34(1):13-8. doi: 10.3928/00989134-20080101-08.

  PMID: 18274300 BACKGROUND

• 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. doi: 10.1093/geront/48.6.721.

  PMID: 19139246 BACKGROUND

• 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.

  PMID: 19215808 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19426941 BACKGROUND

• 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.

  PMID: 19434651 BACKGROUND

• 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.

  PMID: 20078005 BACKGROUND

• 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.1532-5415.2011.03449.x. Epub 2011 Jun 7.

  PMID: 21649633 RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Functional Status

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ann Kolanowski, PhD, RN

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing

Study Record Dates

• First Submitted: October 13, 2006
• First Posted: October 17, 2006
• Study Start: May 1, 2005
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: May 9, 2012

Record last verified: 2012-05

Locations

US (1)