Preventing Aggressive Behavior in Demented Patients - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Preventing Aggressive Behavior in Demented Patients

Resource links provided by NLM:

MedlinePlus related topics: Dementia

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

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

Estimated Enrollment:	10
Study Start Date:	June 2009
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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 have created a manual based on prior work and expert input. Recruitment for pilot patients is now ready to begin. 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

Locations

United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Mark E. Kunik, MD MPH

Michael E DeBakey VA Medical Center

More Information

No publications provided

Responsible Party:	Kunik, Mark - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00622128 History of Changes
Other Study ID Numbers:	MIRECC003
Study First Received:	February 5, 2008
Last Updated:	October 14, 2010
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Behavioral Research
Dementia
Aggression

Additional relevant MeSH terms:

Aggression
Dementia
Behavioral Symptoms
Brain Diseases

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

ClinicalTrials.gov processed this record on February 09, 2012