NCT00622128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2008

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 18, 2010

Status Verified

October 1, 2010

Enrollment Period

1.3 years

First QC Date

February 5, 2008

Last Update Submit

October 14, 2010

Conditions

DementiaAggression

Keywords

Behavioral ResearchDementiaAggression

Outcome Measures

Primary Outcomes (1)

  • Aggression prevention

    one year

Study Arms (1)

1

EXPERIMENTAL

Pilot study. Developing intervention

Behavioral: Preventing Aggressive Behavior in Demented Patients

Interventions

Preventing Aggressive Behavior in Demented PatientsBEHAVIORAL

Preventing Aggressive Behavior in Demented Patients

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of dementia,
  • caregiver

You may not qualify if:

  • history of aggression,
  • residence of nursing homes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

DementiaAggression

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Mark E. Kunik, MD MPH

    Michael E. DeBakey VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 22, 2008

Study Start

June 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 18, 2010

Record last verified: 2010-10

Locations

US(1)