Preventing Aggressive Behavior in Demented Patients - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00622128

Purpose

The purpose of this study is to develop and pilot test and non-pharmacological intervention designed to prevent the occurence of aggression in persons with dementia.

Condition	Intervention	Phase
Dementia Aggression	Behavioral: Preventing Aggressive Behavior in Demented Patients	Phase III

MedlinePlus related topics: Dementia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Preventing Aggressive Behavior in Demented Patients

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Aggresion prevention [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	February 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pilot study. Developing intervention	Behavioral: Preventing Aggressive Behavior in Demented Patients Preventing Aggressive Behavior in Demented Patients

Detailed Description:

An expert panel has met to review the investigators' prior work and literature to help create a non-pharmacological intervention designed to prevent the incidence of aggression. The investigators are now compiling evidence based modules to create an intervention which will piloted in 5-10 patients. The purpose of the pilot will be to further adapt the intervention, assess feasibility, and examine recruitment options.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of dementia,
caregiver

Exclusion Criteria:

history of aggression,
residence of nursing homes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622128

Contacts

Contact: Mark E Kunik, MD MPH	(713) 794-8639	mkunik@bcm.tmc.edu
Contact: Brenda Schubert	(713) 791-1414	Brenda.Schubert@va.gov

Locations

United States, Texas
VA Medical Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Mark E. Kunik, MD MPH

Department of Veterans Affairs

More Information

Responsible Party:	Department of Veterans Affairs ( Kunik, Mark - Principal Investigator )
Study ID Numbers:	MIRECC003
Study First Received:	February 5, 2008
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00622128
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Behavioral Research
Dementia
Aggression

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Diseases
Brain Diseases
Aggression

Dementia
Cognition Disorders
Delirium
Behavioral Symptoms

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009