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Preventing Aggressive Behavior in Demented Patients (PAVeD)

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ClinicalTrials.gov Identifier: NCT00622128
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : October 18, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Dementia Aggression Behavioral: Preventing Aggressive Behavior in Demented Patients Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Aggressive Behavior in Demented Patients
Study Start Date : June 2009
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Pilot study. Developing intervention
Behavioral: Preventing Aggressive Behavior in Demented Patients
Preventing Aggressive Behavior in Demented Patients


Outcome Measures

Primary Outcome Measures :
  1. Aggression prevention [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of dementia,
  • caregiver

Exclusion Criteria:

  • history of aggression,
  • residence of nursing homes
Contacts and Locations

Information from the National Library of Medicine

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): NCT00622128


Locations
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Mark E. Kunik, MD MPH Michael E DeBakey VA Medical Center
More Information

Responsible Party: Kunik, Mark - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00622128     History of Changes
Other Study ID Numbers: MIRECC003
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: October 18, 2010
Last Verified: October 2010

Keywords provided by VA Office of Research and Development:
Behavioral Research
Dementia
Aggression

Additional relevant MeSH terms:
Dementia
Aggression
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Behavioral Symptoms