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Preventing Aggressive Behavior in Demented Patients (PAVeD)

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00622128
First received: February 5, 2008
Last updated: October 14, 2010
Last verified: October 2010
History of Changes
  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 3

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 May 22, 2013