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Treatment Routes for Exploring Agitation (TREA)

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ClinicalTrials.gov Identifier: NCT00820859
Recruitment Status : Unknown
Verified July 2009 by National Institute on Aging (NIA).
Recruitment status was:  Recruiting
First Posted : January 12, 2009
Last Update Posted : July 3, 2009
Sponsor:
Information provided by:
National Institute on Aging (NIA)

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dementia Behavior Problems Behavioral: TREA (Treatment Routes for Exploring Agitation) Behavioral: Placebo Control Group Not Applicable

Detailed Description:

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Agitation in the Nursing Home
Study Start Date : June 2006
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Behavioral: TREA (Treatment Routes for Exploring Agitation)
Individualized non-pharmacological treatment plan for agitation
Active Comparator: 2 Behavioral: Placebo Control Group
A presentation on the treatment of behavior problems in dementia given to the staff caregivers of the comparison group


Outcome Measures
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Primary Outcome Measures :
  1. Agitation Behavior Mapping Instrument (ABMI) [ Time Frame: 10 days of intervention vs. 10 days of baseline ]

Secondary Outcome Measures :
  1. affect/mood measured by Lawton's behavior stream assessment [ Time Frame: 10 days of intervention vs. 10 days of baseline ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820859


Contacts
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Contact: Jiska Cohen-Mansfield, PhD 301-770-8453 cohen-mansfield@hebrew-home.org
Contact: Marcia S. Marx, PhD 301-770-8451 marx@hebrew-home.org

Locations
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United States, Maryland
Research Institute on Aging Recruiting
Rockville, Maryland, United States, 20814
Contact: Jiska Cohen-Mansfield, PhD, ABPP    301-770-8453    cohen-mansfield@hebrew-home.org   
Contact: Marcia Marx, PhD    301-770-8451    marx@hebrew-home.org   
Principal Investigator: Jiska Cohen-Mansfield, PhD, ABPP         
Sub-Investigator: Marcia Marx, PhD         
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Jiska Cohen-Mansfield, PhD Research Institute on Aging
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jiska Cohen-Mansfield, Ph.D., Director, Research Institute on Aging
ClinicalTrials.gov Identifier: NCT00820859    
Other Study ID Numbers: IA0144
5R01AG010172-11 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: July 3, 2009
Last Verified: July 2009
Keywords provided by National Institute on Aging (NIA):
Cognition disorder
nursing home residents
agitation
behavior disorder
Additional relevant MeSH terms:
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Psychomotor Agitation
Problem Behavior
Nervous System Diseases
Dyskinesias
 Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Behavioral Symptoms