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Alzheimer's DiseasePhase 2NCT00388544

Enhancing Quality of Life for Nursing Home Residents

A Phase 2 study testing Activity matched to interest, Activity matched to function and Activity matched to both interest and function in people with Alzheimer's Disease, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Activity matched to interest, Activity matched to function and Activity matched to both interest and function
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteUnited States
Study dates
May 2005to Feb 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Nursing homes in Central and Northeast Pennsylvania

    University Park, Pennsylvania, 16802

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Activity matched to interest, Activity matched to function, Activity matched to both interest and function
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Activity matched to interestBehavioural

    Recreational activities are tailored to subject's style of interest

  • Activity matched to functionBehavioural

    Recreational activities are tailored to subjects physical and cognitive functioning

  • Activity matched to both interest and functionBehavioural

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

Study groups in NCT00388544
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Behavioral: Activity matched to interest
2ExperimentalNot described
Receives: Behavioral: Activity matched to function
3ExperimentalNot described
Receives: Behavioral: Activity matched to both interest and function
4No interventionRecreational activities are not tailored to either style of interest or function

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Agitation

    Measured: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period

  2. Passivity

    Measured: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period

Secondary outcomes (3)

  1. Mood

    Measured: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period

  2. Affect

    Measured: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period

  3. Engagement

    Measured: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2006 (estimated)
  2. Study startMay 2005
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00388544
Sponsor's protocol ID
19150
Other IDs
R01NR008910, R01NR008910-01A1
Status last verified
May 2012
First submitted
13 Oct 2006
Last updated
9 May 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15983178

  • 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.

    PubMed 16027564

  • 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.

    PubMed 16442470

  • 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.

    PubMed 16526585

  • 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.

    PubMed 17010825

  • 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.

    PubMed 17190404

  • 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.

    PubMed 16430433

  • 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.

    PubMed 17062551

  • 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.

    PubMed 17378465

  • 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.

    PubMed 17284553

  • 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. doi: 10.3928/00989134-20080101-08.

    PubMed 18274300

  • 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.

    PubMed 19139246

  • 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.

    PubMed 19215808

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Activity matched to interest, Activity matched to function and Activity matched to both interest and function in people with Alzheimer's Disease, run by Penn State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00388544, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2012.

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