Rockville, Maryland 20814


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

IA0144


NCT ID:

NCT00820859


Secondary ID:

5 R01 AG10172-11


Study Acronym:

TREA


Brief Title:

Treatment Routes for Exploring Agitation


Official Title:

Treatment of Agitation in the Nursing Home


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Aging (NIA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Jiska Cohen-Mansfield, PhD
Principal Investigator
Research Institute on Aging
Primary Contact:Jiska Cohen-Mansfield, PhD
301-770-8453
cohen-mansfield@hebrew-home.org
Backup Contact:Marcia S. Marx, PhD
301-770-8451
marx@hebrew-home.org

Study Dates

Start Date:June 2006
Completion Date:June 2011
Completion Type:Anticipated
Primary Completion Date:June 2011
Primary Completion Type:Anticipated
Verification Date:July 2009
Last Changed Date:July 1, 2009
First Received Date:January 8, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:affect/mood measured by Lawton's behavior stream assessment
Time Frame:10 days of intervention vs. 10 days of baseline
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Agitation Behavior Mapping Instrument (ABMI)
Time Frame:10 days of intervention vs. 10 days of baseline
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:TREA (Treatment Routes for Exploring Agitation)
Description:Individualized non-pharmacological treatment plan for agitation
Arm Name:1
Intervention Type:Behavioral
Name:Placebo Control Group
Description:A presentation on the treatment of behavior problems in dementia given to the staff caregivers of the comparison group
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:Active Comparator
Arm Name:2

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Aging (NIA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84.
PMID:2715584
Reference Type:Reference
Citation:Cohen-Mansfield J, Libin A, Marx MS. Nonpharmacological treatment of agitation: a controlled trial of systematic individualized intervention. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):908-16.
PMID:17702884
Reference Type:Reference
Citation: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. Epub 2008 Apr 3.
PMID:18394647

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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