Recruiting

Agitation

Sponsor:

National Institute on Aging (NIA)

Code:

NCT00820859

Conditions

Dementia

Behavior Problems

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

TREA (Treatment Routes for Exploring Agitation)

Placebo Control Group

Study Details

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.

Conditions

Dementia

Behavior Problems

Study ID

NCT00820859

Start date

Jun, 2006

Status verified date

Jul, 2009

Completion date

Jun, 2011

Anticipated

Primary completion date

Jun, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

active comparator: 2

Interventions

TREA (Treatment Routes for Exploring Agitation)

Individualized non-pharmacological treatment plan for agitation

Placebo Control Group

A presentation on the treatment of behavior problems in dementia given to the staff caregivers of the comparison group

Primary outcome measure

  • Agitation Behavior Mapping Instrument (ABMI) [ Time Frame: 10 days of intervention vs. 10 days of baseline ]

Central Contacts and Locations

Central contacts

Jiska Cohen-Mansfield, PhD

301-770-8453cohen-mansfield@hebrew-home.org

Marcia S. Marx, PhD

301-770-8451marx@hebrew-home.org

Locations

Research Institute on Aging

Recruiting

Rockville, Maryland, United States, 20814

Contacts

Jiska Cohen-Mansfield, PhD, ABPP

301-770-8453cohen-mansfield@hebrew-home.org

Marcia Marx, PhD

301-770-8451marx@hebrew-home.org

Principal Investigator:

Jiska Cohen-Mansfield, PhD, ABPP

More Information

Sponsor

National Institute on Aging (NIA)

Last update posted

Jul 3, 2009

Last verified

Jul, 2009

Keywords

  • Cognition disorder
  • nursing home residents
  • agitation
  • behavior disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute on Aging (NIA) on 2009-07-03.