Treatment Routes for Exploring Agitation (TREA)

July 1, 2009 updated by: National Institute on Aging (NIA)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20814
        • Recruiting
        • Research Institute on Aging
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jiska Cohen-Mansfield, PhD, ABPP
        • Sub-Investigator:
          • Marcia Marx, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Agitation Behavior Mapping Instrument (ABMI)
Time Frame: 10 days of intervention vs. 10 days of baseline
10 days of intervention vs. 10 days of baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
affect/mood measured by Lawton's behavior stream assessment
Time Frame: 10 days of intervention vs. 10 days of baseline
10 days of intervention vs. 10 days of baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Jiska Cohen-Mansfield, PhD, Research Institute on Aging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Estimate)

July 3, 2009

Last Update Submitted That Met QC Criteria

July 1, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0144
  • 5R01AG010172-11 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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