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
|Condition or disease||Intervention/treatment||Phase|
|Dementia Behavior Problems||Behavioral: TREA (Treatment Routes for Exploring Agitation) Behavioral: Placebo Control Group||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- Agitation Behavior Mapping Instrument (ABMI) [ Time Frame: 10 days of intervention vs. 10 days of baseline ]
- affect/mood measured by Lawton's behavior stream assessment [ Time Frame: 10 days of intervention vs. 10 days of baseline ]
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
|Contact: Jiska Cohen-Mansfield, PhDfirstname.lastname@example.org|
|Contact: Marcia S. Marx, PhDemail@example.com|
|United States, Maryland|
|Research Institute on Aging||Recruiting|
|Rockville, Maryland, United States, 20814|
|Contact: Jiska Cohen-Mansfield, PhD, ABPP 301-770-8453 firstname.lastname@example.org|
|Contact: Marcia Marx, PhD 301-770-8451 email@example.com|
|Principal Investigator: Jiska Cohen-Mansfield, PhD, ABPP|
|Sub-Investigator: Marcia Marx, PhD|
|Principal Investigator:||Jiska Cohen-Mansfield, PhD||Research Institute on Aging|