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Preventing Aggressive Behavior in Demented Patients (PAVeD)

Primary Purpose

Dementia, Aggression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Preventing Aggressive Behavior in Demented Patients
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia focused on measuring Behavioral Research, Dementia, Aggression

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of dementia,
  • caregiver

Exclusion Criteria:

  • history of aggression,
  • residence of nursing homes

Sites / Locations

  • Michael E DeBakey VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Pilot study. Developing intervention

Outcomes

Primary Outcome Measures

Aggression prevention

Secondary Outcome Measures

Full Information

First Posted
February 5, 2008
Last Updated
October 14, 2010
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00622128
Brief Title
Preventing Aggressive Behavior in Demented Patients
Acronym
PAVeD
Official Title
Preventing Aggressive Behavior in Demented Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Aggression
Keywords
Behavioral Research, Dementia, Aggression

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Pilot study. Developing intervention
Intervention Type
Behavioral
Intervention Name(s)
Preventing Aggressive Behavior in Demented Patients
Intervention Description
Preventing Aggressive Behavior in Demented Patients
Primary Outcome Measure Information:
Title
Aggression prevention
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of dementia, caregiver Exclusion Criteria: history of aggression, residence of nursing homes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark E. Kunik, MD MPH
Organizational Affiliation
Michael E. DeBakey VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Preventing Aggressive Behavior in Demented Patients

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