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Dementia | Treatment Routes for Exploring Agitation

Dementia research study

What is the primary objective of this study?

The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.

Who is eligible to participate?

Inclusion Criteria: - Age 60 or older - Diagnosis of dementia derived from the resident's medical chart at the facility or from an attending physician, as based on DSM-IV criteria and the Report of the NINCDS-ADRDA - Resident of the facility for at least three weeks so that nursing staff members know the resident well enough to accurately assess him or her - Identified by nursing staff to exhibit either verbal agitation or physical non-aggressive agitation at least several times a day Exclusion Criteria: - Lifelong diagnosis of schizophrenia - Bipolar disorder diagnosed prior to onset of dementia - Diagnosis of premorbid mental retardation - Judged by direct-care nursing staff to have a life expectancy of less than 3 months - Expected to leave the nursing home (either to enter the hospital or to go home) within the next 4 months - Agitation manifested less than 6 times a day

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dementia

Behavior Problems

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:TREA (Treatment Routes for Exploring Agitation)Individualized non-pharmacological treatment plan for agitation

Behavioral:Placebo Control GroupA presentation on the treatment of behavior problems in dementia given to the staff caregivers of the comparison group

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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Study Status

Unknown status

Start Date: June 2006

Completed Date: June 2011

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Agitation Behavior Mapping Instrument (ABMI)

Secondary Outcome: affect/mood measured by Lawton's behavior stream assessment

Study sponsors, principal investigator, and references

Principal Investigator: Jiska Cohen-Mansfield, PhD

Lead Sponsor: National Institute on Aging (NIA)

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00820859

Cohen-Mansfield J. Agitated behavior in persons with dementia: the relationship between type of behavior, its frequency, and its disruptiveness. J Psychiatr Res. 2008 Nov;43(1):64-9. doi: 10.1016/j.jpsychires.2008.02.003. Epub 2008 Apr 3.

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