Treatment Routes for Exploring Agitation



Status:Completed
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:60 - Any
Updated:4/2/2016
Start Date:June 2006
End Date:June 2011
Contact:Jiska Cohen-Mansfield, PhD
Email:cohen-mansfield@hebrew-home.org
Phone:301-770-8453

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Treatment of Agitation in the Nursing Home

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.

Clinicians often refer to elderly persons under their care as "agitated." However, agitation
is not a diagnosis, but rather, a descriptive term pertaining to a group of behavioral signs
and symptoms, defined as socially inappropriate verbal, vocal, or motor (physical) activity
that is not judged by an outside observer to result directly from the needs or confusion of
the agitated individual. While the literature reports positive effects of
non-pharmacological interventions, most studies tend to be based on small samples and do not
yield statistically significant results. This study examines the impact of non-pharmacologic
interventions tailored through an algorithm labeled TREA (Treatment Routes for Exploring
Agitation) using a large, well-controlled, systematic research design.

TREA is an objective, systematic method for developing individualized non-pharmacological
treatment plans based on an analysis of the agitated person's unmet needs, past and current
preferences, past role-identity, cognitive, mobility, and sensory abilities/limitations, and
possible causes for particular agitated behaviors. The methodology calls for ascertaining
the type of agitated behavior and the most likely etiology, and then matching the
intervention to the etiology and to the participant's characteristics.

The protocol involves the following steps:

- Baseline assessment - using standardized assessments (e.g., MMSE, ABMI, CMAI,
Self-identity in dementia), collecting background demographic and medical information
as well as systematic observations of the agitated resident

- Intervention exploration - after analyzing potential unmet needs as well as
preferences, abilities and identities of each participant, investigators develop a list
of potentially successful interventions, examining the effectiveness of a wide range of
interventions, from family videos to manipulatives (e.g., puzzles, a tool kit)

- Intervention (treatment) phase — Interventions are systematically provided during the
hours of highest agitation (determined at baseline) and observations are conducted at
the same time. The treatment phase lasts for 10 days. The placebo control group
includes a presentation to staff members as to how to intervene with behavior problems
and similar observations of residents.

- Follow-up phase includes repeated assessments without interventions.

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
We found this trial at
1
site
Rockville, Maryland 20814
?
mi
from
Rockville, MD
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