Improving Mood and Behavior in Assisted Living Residents Through Skills Training for Their Caregivers

Alzheimer Disease Clinical Trial

Official title:

Improving Affect and Behavior in Assisted Living Residents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255866
• Other study ID #: 26082-ED
• Secondary ID: R21MH069651DSIR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 16, 2005
• Last updated: November 30, 2015
• Start date: January 2004
• Est. completion date: December 2006

Study information

• Verified date: December 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

Assisted living is rapidly becoming one of the most common methods of caring for older adults with dementia in long-term care. Over half of assisted living residents have dementia and many exhibit affective and behavioral problems related to the condition; residents' care and quality of life may suffer as a result of these problems. Despite the seriousness of this condition, interventions to teach direct care staff how to care for these residents are limited. This study will develop a program for teaching assisted living staff how to deal with the issues of patients with dementia and reduce mood and behavioral problems among this population.

Caregivers will be randomly assigned to attend skills training sessions as two 4-hour workshops, four 30 minute individual training sessions, or two 30 minute in-services. Training will focus on dementia, depression and anxiety, the incidence of behavior problems, and skills and techniques for alleviating care challenges associated with behavior problems. Caregivers will complete self-report scales and questionnaires at the beginning and at the end of the study; these measures will assess job satisfaction, reactions to resident behavioral problems, and job skills. Residents will also be recruited for this study; they will complete questionnaires about their depressive episodes, anxiety, behavioral problems, and quality of life at the beginning and at the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria for Assisted Living Staff

• 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

Inclusion Criteria for Assisted Living Residents:

• 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

Exclusion Criteria for Assisted Living Residents:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Behavioral:
• Skills training for the care of dementia patients

Locations

Country	Name	City	State
United States	Rush University School of Nursing	Chicago	Illinois
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skills to effectively deal with resident behavioral problems
Secondary	Resident depression, anxiety, behavioral problems, and quality of life