NCT00255866

Brief Summary

This study will develop a treatment program to reduce mood and behavior problems in assisted living residents who have dementia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2004

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2013

Enrollment Period

2.9 years

First QC Date

November 16, 2005

Last Update Submit

November 30, 2015

Conditions

DementiaAlzheimer Disease

Keywords

Assisted Living FacilitiesAgedElderlyCaregivers

Outcome Measures

Primary Outcomes (1)

  • Skills to effectively deal with resident behavioral problems

Secondary Outcomes (1)

  • Resident depression, anxiety, behavioral problems, and quality of life

Interventions

Skills training for the care of dementia patientsBEHAVIORAL

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Work in the assisted living residence for at least 6 months prior to study entry
  • Work in the assisted living residence at least 5 days a week, for at least 4 hours a day on day or afternoon-evening shifts
  • Provide direct care for at least 1 assisted living resident
  • Agree to attend all training sessions and complete assessment forms
  • Able to speak, read, and understand English at a 6th grade level
  • Diagnosis of dementia
  • Identified by caregiving staff as having mood or behavioral problems
  • Have lived at the assisted living residence for at least 3 months prior to study entry
  • Have a family member with power of attorney

You may not qualify if:

  • Plan to receive medication for affective or behavioral problems during the study
  • History of alcohol or drug abuse
  • Have attempted suicide within 1 year prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Rush University School of Nursing

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Linda Teri, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 21, 2005

Study Start

January 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

December 2, 2015

Record last verified: 2013-12

Locations

US(2)